[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cerebral-small-vessel-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cerebral-small-vessel-diseases":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,51,74,104,127,153,178,205,227,252,279,307,337,361,386,413,436,458,493,517,537,561,579,606,628],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100627085","mri-based-lesion-differentiation-in-older-patients-with-multiple-sclerosis-100627085",false,"NCT07444047","MRI-Based Lesion Differentiation in Older Patients With Multiple Sclerosis","Quantitative Susceptibility Mapping for Lesion Differentiation in Aging Multiple Sclerosis","Inclusion Criteria Multiple Sclerosis (MS) cohort (AgeMS):\n\n* Age 50-70 years\n* Clinically confirmed diagnosis of multiple sclerosis\n* Participation in the AgeMS study at Oslo University Hospital\n\nInclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:\n\n* Age 50-80 years\n* Radiological evidence of hypertensive small vessel disease on MRI\n* Good clinical recovery following transient ischemic attack (TIA), minor stroke, or stroke mimic diagnosis\n\nExclusion Criteria Multiple Sclerosis (MS) cohort:\n\n* MRI contraindications\n* Severe psychiatric comorbidity\n* Major functional disability unrelated to MS or CSVD\n\nExclusion Criteria Cerebral Small Vessel Disease (cSVD) control cohort:\n\n* MRI contraindications\n* Probable or definite cerebral amyloid angiopathy according to Boston criteria 2.0\n* Genetic or inflammatory vasculopathies\n* Persistent neurological deficits\n* Severe psychiatric comorbidity\n* Major functional disability unrelated to CSVD","ALL","50 Years","80 Years",{"count":21,"type":22},1000,"ESTIMATED","OBSERVATIONAL","This study investigates whether an advanced MRI technique called Quantitative Susceptibility Mapping (QSM) can improve the differentiation of white matter lesions in people aged 50-70 years with multiple sclerosis (MS). In older individuals with MS, white matter changes seen on MRI may be related to MS or to other types of white matter changes, most commonly age-related changes or chronic small vessel disease. These conditions can appear similar on conventional MRI scans, making interpretation challenging.\n\nParticipants will undergo routine clinical MRI, including a short additional QSM sequence, as well as brief cognitive and physical assessments. A comparison group with cerebral small vessel disease will also be included.\n\nThe goal of the study is to determine whether QSM can provide more precise lesion characterization and support more accurate clinical interpretation of MRI findings in older patients with MS.",[26,27],"Multiple Sclerosis (MS)","Cerebral Small Vessel Diseases",[29,30,31,32,33,34,35,36,37],"Quantitative Susceptibility Mapping","QSM","White Matter Lesions","MRI","Lesion Differentiation","Aging","Neuroimaging","Demyelination","Small vessel Disease","RECRUITING","2026-05-28",{"date":41,"type":42},"2026-06-01","ACTUAL",{"date":44,"type":42},"2026-05-11",{"date":46,"type":22},"2031-12-31",{"name":48,"class":49},"Oslo University Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":50},"100548083","retinal-vessel-leakage-in-cerebral-small-vessel-disease-100548083","NCT06416371","Retinal Vessel Leakage in Cerebral Small Vessel Disease","Retinal Vessel Leakage in Cerebral Small Vessel Disease: a Sub-study of the Mild Stroke Study 3","Inclusion Criteria:\n\n* Membership in the Mild Stroke Study 3 cohort\n* Contrast enhanced MRI within 12 months\n* Clear optical media in both eyes, as assessed by study investigator\n* Best corrected visual acuity (near vision) ≥N36\n\nExclusion Criteria:\n\n* Any condition known to cause retinal leakage (i.e., worse than background diabetic retinopathy, retinal vein occlusion, active uveitis, wet age-related macular degeneration, malignant hypertension)\n* Previous treatment for retinal leakage (retinal laser, intravitreal anti-VEGF)\n* Recent eye surgery\n* Shallow anterior chambers as assessed by torch test\n* Pregnancy, renal failure\n* Severe dementia\n* Known allergy to fluorescein\n* History of allergy such as food or drug induced urticaria or history of bronchial asthma\n* Any other severe or acute medical or psychiatric conditions\n* Inability to give informed consent","18 Years",{"count":60,"type":22},40,"The goal of this observational study is to learn about leakage from retinal vessels in cerebral small vessel disease. The main questions it aims to answer are:\n\n* Does retinal vessel leakage occur in cerebral small vessel disease?\n* If it does, is the severity of retinal vessel leakage similar to the severity of cerebral small vessel disease generally?\n\nParticipants will be tested using fluorescein angiography. This involves an intravenous injection of fluorescent dye, and is a very sensitive way to find leakage from retinal blood vessels.\n\nParticipants will have already had brain scans and other examinations and tests to measure the severity of their cerebral small vessel disease. Our new retinal images will complement the information from these previous tests.",[27,63,64],"Lacunar Stroke","Vascular Dementia","2026-03-02",{"date":67,"type":42},"2026-03-04",{"date":69,"type":42},"2025-01-13",{"date":71,"type":22},"2029-02-15",{"name":73,"class":49},"University of Edinburgh",{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":83,"targetDuration":85,"studyType":23,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":50},"100475646","taiwan-associated-genetic-and-nongenetic-small-vessel-disease-100475646","NCT05473637","Taiwan Associated Genetic and Nongenetic Small Vessel Disease","Deciphering, Construction and Validation of Magnetic Resonance Imaging Maps, Clinical Features and Outcomes in Genetic and Nongenetic Cerebral Small Vessel Diseases","TAG-SVD","Inclusion Criteria:\n\nParticipants must have at least one of the following symptoms\u002Fsigns or history\n\n* stroke (especially small vessel occlusion type of ischaemic stroke, spontaneous ICH or young stroke)\n* cognitive impairment or dementia\n* gait disturbance\n* parkinsonism (especially vascular parkinsonism features)\n* headache (especially migraine)\n* positive family history of hereditary CSVD\n* MRI evidence of CSVD (MRI may be done for other reasons), including mild to moderate white matter hyper intensity, any lacune, or any cerebral microbleed\n\nExclusion Criteria:\n\n* MRI evidence of CSVD due to other inflammatory, malignancy, or structural lesions\n* patients or family members not willing to sign informed consent",true,{"count":84,"type":22},500,"2 Years","The TAG-SVD enrolled patients with clinical and neuroimaging features of cerebral small vessel disease (CSVD). All enrolled patients will receive next-generation sequence (NGS) with probes designed to target five candidate CSVD genes, and patients will be divided into genetic or non-genetic groups accordingly. Their clinical features and outcome will be followed for at least 2 years.",[27,88,89,90,91,92,93,94],"Cadasil","HTRA1-Related Autosomal Dominant Cerebral Angiopathy","COL4A1-Related Brain Small Vessel Disease With Haemorrhage","Fabry Disease","Magnetic Resonance Imaging","Next-generation Sequencing","Stroke","2026-01-15",{"date":97,"type":42},"2026-01-20",{"date":99,"type":42},"2019-01-01",{"date":101,"type":22},"2028-12-31",{"name":103,"class":49},"National Taiwan University Hospital",{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":112,"targetDuration":114,"studyType":23,"phases":4,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":50},"100619242","registry-study-of-cerebral-small-vessel-disease-100619242","NCT07342075","Registry Study of Cerebral Small Vessel Disease","Real-world Patient Registry Study of Cerebral Small Vessel Disease","DZM-CSVD-R","Inclusion Criteria:\n\n1. Age above 50 years (including 50-year-old);\n2. MRI confirmed the presence of typical imaging changes of CSVD;\n3. Voluntary participation in the study and be willing to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;\n2. Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);\n3. Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);\n4. Severe hepatic, renal, or cardiac insufficiency (ALT or AST \\>2 times the upper limit of normal, or serum creatinine \\>1.5 times the upper limit of normal, or New York Heart Association \\[NYHA\\] functional class III or IV);\n5. Patients with psychiatric disorders that affect study medication administration and evaluation;\n6. Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);\n7. Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;\n8. Participation in other clinical trial projects.",{"count":113,"type":22},50,"6 Months","The incidence of cerebral small vessel disease (CSVD) increases with age, affecting approximately 5% of individuals over 50 years old and nearly all individuals over 90 years old. CSVD is also the most important vascular factor contributing to cognitive decline, with 45% of dementia patients attributed to CSVD. Existing interventions are similar to secondary prevention strategies for cardiovascular and cerebrovascular diseases, and no specific therapies are currently available.\n\nCSVD-related cognitive impairment (CSVDCI) predominantly involves attention, processing speed, and executive functions, with relatively preserved memory function, and may be accompanied by non-cognitive clinical manifestations such as gait disturbances, emotional and behavioral disorders, and bladder dysfunction. Although CSVDCI can be classified under vascular cognitive impairment (VCI), there are certain differences in its clinical manifestations.\n\nIn summary, it is necessary to develop more targeted treatments for CSVD. We attempt to establish a \"symptom-tongue coating-gut microbiota-imaging\" system to provide data support for the subsequent exploration of CSVD treatments based on traditional Chinese medicine (TCM) syndrome differentiation and treatment.",[27,117,118],"Cognitive Impairment","Diffusion Tensor Imaging","2026-01-06",{"date":95,"type":42},{"date":122,"type":42},"2025-11-13",{"date":124,"type":22},"2026-12-31",{"name":126,"class":49},"Dongzhimen Hospital, Beijing",{"id":128,"slug":129,"hasResults":12,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":50},"100613833","songling-xuemaikang-capsules-for-cerebral-small-vessel-disease-100613833","NCT07271732","Songling Xuemaikang Capsules for Cerebral Small Vessel Disease","Songling Xuemaikang Capsules for Cerebral Small Vessel Disease: A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study","SXC-CSVD","Inclusion Criteria:\n\n1. Age 55-75 years (both inclusive);\n2. MRI has moderate to (1) severe white matter lesions (deep Fazekas score \\> 1 or paraventricular Fazekas score \\> 2 or modified Fazekas score \\> 1), or (2) mild white matter hyperintensity (deep Fazekas score = 1 or paraventricular Fazekas score = 2 or modified Fazekas score = 1) combined with more than 1 lacunar infarction;\n3. History of essential hypertension; Hypertension is defined as SBP consistently greater than 140 mmHg and\u002For DBP consistently greater than 90 mmHg, or those requiring clinical antihypertensive treatment.\n4. Meeting the diagnostic criteria for hyperactivity of liver yang pattern; Hyperactivity of liver yang pattern is defined as having at least three of the following six symptoms: headache, dizziness or vertigo, irritability, flushed face, red eyes, and yellow tongue coating.\n5. Functional independence in daily living (Modified Rankin Scale ≤2);\n6. Voluntary participation in the study and be willing to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Patients with acute ischemic stroke or acute intracranial hemorrhage (e.g., epidural hematoma, subdural hematoma, subarachnoid hemorrhage, intracerebral hemorrhage, etc.) or a history of cerebral infarction (non-lacunar) or intracranial hemorrhage within the past 3 months;\n2. Symptomatic stenosis of the middle cerebral artery and\u002For internal carotid artery (stenosis rate ≥50%), or asymptomatic stenosis of the middle cerebral artery and\u002For internal carotid artery (stenosis rate ≥70%);\n3. Untreated cerebrovascular malformations or intracranial aneurysms (diameter \\>3 mm);\n4. Significant non-vascular white matter lesions (e.g., multiple sclerosis, adult-onset leukoencephalopathy, metabolic encephalopathy, etc.);\n5. Patients with a history of cognitive impairment due to other causes (e.g., normal pressure hydrocephalus, Alzheimer's disease, Parkinson's disease, multiple sclerosis, encephalitis, etc.);\n6. A history of intracranial or intramedullary surgery within the past year;\n7. Severe hepatic, renal, or cardiac insufficiency (ALT or AST \\>2 times the upper limit of normal, or serum creatinine \\>1.5 times the upper limit of normal, or New York Heart Association \\[NYHA\\] functional class III or IV);\n8. Severe three-vessel coronary artery disease as shown by coronary computed tomography angiography or coronary angiography within 90 days or suffering from frequent angina;\n9. Refractory hyperglycemia uncontrolled by medication (fasting blood glucose \\>10 mmol\u002FL, or HbA1c \\>8.0%);\n10. Patients with severe diseases such as cancer and a life expectancy of less than 2 years;\n11. Patients with psychiatric disorders that affect study medication administration and evaluation;\n12. Previous allergy or intolerance to Songling Xuemaikang Capsules;\n13. Contraindications to MRI examination (e.g., claustrophobia, presence of an implantable pacemaker, etc.);\n14. Patients unable to comply with follow-up examinations or other study procedures due to residential location or other reasons;\n15. Participation in other clinical trial projects.","55 Years","75 Years",{"count":138,"type":22},90,"INTERVENTIONAL",[141],"NA","Cerebral small vessel disease (CSVD) is a common age-related microvascular disease related to the slow accumulation of damage to small arteries, veins, and capillaries. Hypertension is a risk factor for cerebrovascular disease, and its damage to the vascular endothelium is one of the key contributing factors to the pathogenesis of CSVD. CSVD has an insidious onset, and patients may exhibit no clinical symptoms in the early stage. Common clinical manifestations of chronic CSVD include vascular dementia, depression, gait disturbance, and abnormalities in swallowing and urinary functions. There is currently no specific treatment for CSVD.\n\nExisting studies have shown that Songling Xuemaikang capsule (SXC) combined with antihypertensive drugs exerted significant effects on systolic blood pressure (SBP), diastolic blood pressure (DBP), 24-hour SBP, and 24-hour DBP, while also improving symptoms of hypertension. Animal experiments have demonstrated that SXC can reduce apoptosis and alleviate cerebral ischemia-reperfusion injury, exerting neuroprotective effects. Additionally, a previously completed multicenter, randomized, double-blind, non-inferiority-designed clinical trial by the team, conducted in patients with primary hypertension, showed that SXC were non-inferior to losartan potassium in reducing diastolic blood pressure. Therefore, exploring the therapeutic potential of SXC in CSVD is highly necessary.\n\nThis project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of SXC in the treatment of hypertension with CSVD. A total of 90 subjects who met the subject screening criteria are planned to be enrolled, with 45 patients in the test group and 45 patients in the placebo group.",[144,27],"Hypertension","NOT_YET_RECRUITING","2025-12-06",{"date":148,"type":42},"2025-12-09",{"date":150,"type":22},"2025-12-10",{"date":124,"type":22},{"name":126,"class":49},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":4,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":161,"targetDuration":4,"studyType":139,"phases":163,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100612358","phase-3-isosorbide-mononitrate-and-butylphthalide-to-reduce-the-risk-of-disability-in-patients-with-acute-lacunar-stroke-impact-100612358","NCT07252544","Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke (IMPACT)","Isosorbide Mononitrate and Butylphthalide to Reduce the Risk of Disability in Patients With Acute Lacunar Stroke: a 2×2 Factorial Randomized Controlled Trial (IMPACT)","Inclusion Criteria:\n\n1. Age ≥ 30 years;\n2. Clinical lacunar syndrome within 7 days;\n3. Brain CT\u002FMRI after symptom onset:\n\n   1. a relevant (in time and location) acute lacunar infarct;\n   2. if no relevant lesion, symptom duration \\>24 hours, with no other suspected stroke etiologies (such as cerebral hemorrhage, cortical infarction, seizures, etc.)\n4. MoCA score meeting the following criteria:\n\n   1. MoCA ≥ 13 if educated ≤ 6 years;\n   2. MoCA ≥ 15 if 7 ≤ educated ≤ 12 years;\n   3. MoCA ≥ 18 if educated ≥ 13 years；\n5. mRS ≤ 1 prior to this episode;\n6. Patient or a legally authorized representative signed informed consent.\n\nExclusion Criteria:\n\n1. Ischemic stroke of large artery atherosclerosis, cardioembolism, or other etiologies (TOAST classification);\n2. Diagnosed or suspected hereditary CSVD;\n3. Intracerebral hemorrhage within the past 3 months including parenchymal, intraventricular, subarachnoid hemorrhage, subdural\u002Fepidural hematoma;\n4. Neurodegenerative diseases or systemic diseases that may lead to cognitive impairment, such as Alzheimer's disease, mixed dementia, Parkinson's disease, systemic autoimmune diseases, hepatic encephalopathy, or uremic encephalopathy.\n5. Previously diagnosed psychiatric disorders (DSM-5 criteria).\n6. Other active neurological disorders (e.g., recurrent seizures, brain tumors, vascular malformations, untreated aneurysms \\>3 mm).\n7. Hypotension (seated systolic blood pressure \\\u003C100 mmHg), bradycardia (heart rate \\\u003C60 bpm), sick sinus syndrome or severe cardiopulmonary disease.\n8. History of congestive heart failure, acute myocardial infarction or other severe cardiac dysfunctions (NYHA Class III-IV).\n9. Coagulation disorders, bleeding tendency or systemic bleeding, including but not limited to prothrombin time \\>3×upper limit of normal (ULN), platelet count \\\u003C50×109\u002FL, hemophilia, capillary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, or vitreous hemorrhage, etc.\n10. Severe hepatic or renal insufficiency (note: severe hepatic insufficiency is defined as ALT or AST \\> 3×ULN or acute hepatitis, chronic active hepatitis, cirrhosis; severe renal insufficiency is defined as eGFR \\\u003C 45 ml\u002Fmin\u002F1.73m², creatinine clearance \\\u003C 40 ml\u002Fmin, or known chronic kidney disease of stage 3 or higher).\n11. Head trauma, intracranial or spinal surgery, major surgical procedures or severe trauma within the past 4 weeks.\n12. ISMN or NBP use within the past 3 days.\n13. Have contraindications to ISMN or NBP, or allergy to their components.\n14. Have to use the contraindicated drugs of this trial for a long time.\n15. Pregnant, breastfeeding or planning to pregnant during this study.\n16. Unable to tolerate MRI or with MRI contraindications.\n17. Have severe diseases or expected survival \\\u003C12 months.\n18. Participate in other clinical trials within 30 days before this trial.\n19. Unlikely to comply with study procedures and follow-up procedures for whatever reason in the opinion of the research physician.","30 Years",{"count":162,"type":22},3156,[164],"PHASE3","The goal of this multicenter, double-blind, 2×2 factorial randomized controlled trial is to evaluate the efficacy and safety of isosorbide mononitrate, butylphthalide, and their combination in reducing disability in patients with acute lacunar stroke.",[167,168,27],"Stroke, Lacunar","Stroke, Acute Ischemic","2025-11-24",{"date":171,"type":42},"2025-11-26",{"date":173,"type":22},"2025-12-01",{"date":175,"type":22},"2028-02-29",{"name":177,"class":49},"Beijing Tiantan Hospital",{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":19,"enrollmentInfo":185,"targetDuration":4,"studyType":139,"phases":187,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":50},"100608389","phase-2-a-multicenter-randomized-double-blind-placebo-controlled-trial-on-the-treatment-of-hypertensive-intracerebral-hemorrhage-with-naoxuekang-dropping-pills-100608389","NCT07200921","A Multicenter, Randomized, Double-blind, Placebo-controlled Trial on the Treatment of Hypertensive Intracerebral Hemorrhage With Naoxuekang Dropping Pills","TCM-ICH","Inclusion Criteria:\n\n1. Meets the diagnostic criteria for hypertensive intracerebral hemorrhage.\n2. Able to cooperate with a head MRI examination and has imaging manifestations of cerebral small vessel disease (CSVD) (Staals total CSVD burden score ≥ 1).\n3. Supratentorial hemorrhage (volume ≤ 30ml) or infratentorial hemorrhage (volume ≤ 10ml).\n4. Within 7 days of symptom onset.\n5. NIHSS score ≤ 25.\n6. GCS score ≥ 8.\n7. Age between 18 and 80 years (inclusive).\n8. Any gender\n\nExclusion Criteria:\n\n1. Primary intraventricular hemorrhage.\n2. Spontaneous intracerebral hemorrhage due to other causes or secondary intracerebral hemorrhage (e.g., from trauma, vascular malformations, coagulation disorders, hematological diseases, systemic diseases, or tumors).\n3. Planned surgical intervention (including craniotomy for hematoma evacuation, minimally invasive hematoma removal, or ventricular puncture).\n4. Patients with active peptic ulcer, bleeding, or other clear tendency for rebleeding.\n5. Patients with severe hepatic or renal dysfunction (Severe hepatic dysfunction: ALT or AST \\> 3 times the upper limit of normal; Severe renal dysfunction: Serum creatinine \\> 2 times the upper limit of normal).\n6. Suffering from other life-threatening severe diseases with an expected survival time of less than 1 year.\n7. Known allergy to any component of the study drug.\n8. Pregnant women, women planning pregnancy, or lactating women.\n9. Participating in another interventional clinical trial.",{"count":186,"type":22},1950,[188],"PHASE2","This study aims to evaluate the effectiveness and safety of a Chinese medicine-based intervention combined with standard medicine, in reducing composite vascular events in patients with hypertensive intracerebral hemorrhage (HICH).This is a multicenter, randomized, double-blind, placebo-controlled trial. A total of 1950 participants with HICH within 7 days of onset, accompanied by imaging evidence of cerebral small vessel disease, will be enrolled.Participants will be randomly assigned to receive eitherNaoxuekang Dropping Pills or matching placebo for 90 days, in addition to guideline-based standard care.The primary outcome is the incidence of composite vascular events (including ischemic stroke, hemorrhagic stroke, myocardial infarction, vascular death, deep vein thrombosis, and pulmonary embolism) within 1 year.Secondary outcomes include vascular events within 90 days, neurological function (mRS), and cognitive function (MMSE, MoCA) at 90 days and 1 year.Safety will be monitored through adverse event reporting.The results will provide evidence for optimizing secondary prevention strategies in HICH patients.",[191,27],"Hypertensive Intracerebral Hemorrhage",[193,194,195,196],"Hypertensive intracerebral hemorrhage","Cerebral small vessel disease","Naoxuekang Dropping Pills","Randomized controlled trial","2025-09-23",{"date":199,"type":42},"2025-10-01",{"date":201,"type":22},"2025-10-10",{"date":203,"type":22},"2028-11-30",{"name":177,"class":49},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":211,"maxAge":19,"enrollmentInfo":212,"targetDuration":4,"studyType":139,"phases":214,"briefSummary":215,"conditions":216,"keywords":217,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":226,"locationsCount":50},"100560631","intermittent-theta-burst-stimulation-on-cognitive-impairment-of-cerebral-small-vessel-disease-100560631","NCT06579664","Intermittent Theta Burst Stimulation on Cognitive Impairment of Cerebral Small Vessel Disease","Inclusion Criteria：\n\n1. Age 45-80 years old, with no limitation on sex.\n2. Clinical evidence of CVSD as evidenced by one or more of:\n\n   * White matter hyperintensity with Fazekas score ≥2\n   * a lacunar stroke syndrome (e.g. pure motor stroke, pure sensory stroke, sensorimotor stroke, ataxic hemiparesis, or clumsy hand dysarthria syndrome) with a corresponding acute lacunar infarct on diffusion weighted imaging (DWl) for cases imaged (clinically) within 3 weeks of stroke or anatomically compatible lacunar infarct on fluid attenuated inversion recovery (FLAIR)\u002FT1 MRI for cases imaged later after stroke (diameter≤1.5cm).\n3. Independence of daily life (modified Rankin Scale score ≤2).\n4. Mild vascular cognitive impairment (memory and\u002For other cognitive domain abnormalities lasting for at least 3 months) with a MoCA score of 10-22.\n5. Routine, consistent medication for 4 weeks or more.\n\nExclusion Criteria:\n\n1. History of stroke within previous 30 days, including cerebral infarction (diameter \\>15mm), cerebral hemorrhage, subarachnoid hemorrhage;\n2. History of cerebral cortex infarction.\n3. History of cerebrovascular malformation or aneurysmal subarachnoid hemorrhage, or discovery of an untreated aneurysm \\> 3mm.\n4. Carotid or vertebral artery stenosis \\> 50% measured on North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria.\n5. Possible amyloid cerebrovascular disease with at least 2 lobar hemorrhagic lesions (i.e., intracranial hemorrhage, cerebral microbleeds (CMB), cortical superficial siderosis, or convexal subarachnoid hemorrhage) measured on Boston Criteria 2.0; Or at least one lobar hemorrhagic lesion and at least one white matter feature (severe enlarged perivascular space in the centrum semiovale or multiple punctate white matter hyperintensities) without deep hemorrhagic lesion (cerebral hemorrhage or CMB) on T2\\* weighted MRI.\n6. Recorded diagnosis of neurodegenerative diseases (e.g. Alzheimer's disease and Parkinson's disease).\n7. Definite non-vasogenic white matter lesions (e.g. multiple sclerosis, cortical dysplasia in adults, metabolic encephalopathy).\n8. Other psychiatric disorders diagnosed measured on the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) diagnostic criteria; Or apparent suicidal intent.\n9. Unable to tolerate MRI or contraindication to MRI (e.g., claustrophobia).\n10. T1 or T2 weighted MRI shows focal brain injury.\n11. Patients or first-degree relatives with a history of seizures.\n12. Implanted pacemakers, vagus nerve stimulators, deep brain stimulators, or other metal medical devices.\n13. Received transcranial magnetic stimulation therapy within previous 3 months.\n14. Severe organic diseases with expected survival time \\\u003C5 years, such as malignant tumor.\n15. Women of child bearing potential, pregnant or breastfeeding.\n16. Individual who have difficulty communicating verbally to the extent that they are unable to communicate, understand or follow instructions normally, and are unable to cooperate with treatment and evaluation.\n17. Combined with alcohol and drug abuse history.\n18. Unable to be cooperative and complete the follow-up due to geographical or other reasons.\n19. Participated in other clinical trials.","45 Years",{"count":213,"type":22},58,[141],"The cerebral small vessel diseases (CVSD) can cause severe and lasting damage to cognition function while the current available treatment of vascular cognitive impairment (VCI) is limited. The purpose of this study is to explore the feasibility, safety, and efficacy of intermittent Theta Burst Stimulation (iTBS) on cognitive impairment of cerebral small vessel disease.",[27,117],[27,117,218,219],"Intermittent Theta-Burst Stimulation","Personalized Brain Function Sector","2025-09-01",{"date":222,"type":42},"2025-09-08",{"date":224,"type":42},"2025-03-24",{"date":124,"type":22},{"name":177,"class":49},{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":82,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":139,"phases":236,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":50},"100420378","phase-1-retina-is-a-marker-for-cerebrovascular-heath-100420378","NCT04753970","Retina is a Marker for Cerebrovascular Heath","Retinal Vasoreactivity is a Marker for Cerebral Small Vessel Disease Progression","Inclusion Criteria:\n\n* Age ≥18 yo.\n* Diagnosis of CADASIL, sporadic WMD or lobar CMB and age-matched healthy controls (eg. patient's spouse or unrelated friends without SVD)\n\nExclusion Criteria:\n\n* Age\\\u003C18yo\n* Pregnant\n* Breast feeding\n* Unable to follow commands\n* Unable to tolerate MRI",{"count":235,"type":22},100,[237,188],"PHASE1","Cerebral small vessel disease (SVD), present in 80-94% of adults over age 65 years, increases the risk of stroke by 2-fold, and dementia by 2.3-fold. There is currently no treatment to slow SVD progression. This study aims to test whether impaired cerebral and retinal vasoreactivity may serve as biomarker for SVD progression, and to evaluate the safety and efficacy of cilostazol (antiplatelet agent with vasodilatory and anti-inflammatory properties) for the treatment of SVD.",[27,240,241,242],"Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy","Cerebral Microbleeding","Sporadic White Matter Disease","2025-07-21",{"date":245,"type":42},"2025-07-23",{"date":247,"type":42},"2021-02-09",{"date":249,"type":22},"2026-06",{"name":251,"class":49},"Mayo Clinic",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":139,"phases":261,"briefSummary":262,"conditions":263,"keywords":265,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100592917","prospective-randomized-controlled-trial-of-vr-cognitive-training-in-reducing-postoperative-delirium-in-elderly-patients-with-cerebral-small-vessel-disease-undergoing-non-cardiac-surgery-100592917","NCT06999668","Prospective Randomized Controlled Trial of VR Cognitive Training in Reducing Postoperative Delirium in Elderly Patients With Cerebral Small Vessel Disease Undergoing Non-Cardiac Surgery","Inclusion Criteria:\n\nAge ≥ 65 years; Preoperative MRI diagnosis of cerebral small vessel disease (CSVD); Scheduled to undergo non-cardiac, non-intracranial procedures under general anesthesia; Expected surgery duration \\> 2 hours; ASA physical status classification: I-III; No use of cognitive-enhancing medications within 3 months prior to surgery; Willing to participate and provide written informed consent.\n\nExclusion Criteria:\n\nContraindications to cranial MRI (e.g., cardiac pacemaker, metallic implants, etc.); Patients experiencing subjective discomfort (dizziness, nausea, vomiting) during VR device adaptation; Severe visual or auditory impairment; Severe hepatic or renal dysfunction; Pre-existing neuropsychiatric disorders (schizophrenia, epilepsy, Parkinson's disease, delirium, etc.); Inability to complete preoperative neuropsychological assessments (dementia, deaf-mutism, communication disorders); History of cerebrovascular events (stroke, transient ischemic attack, etc.) within 3 months prior to surgery; Current use of sedatives\u002Fantidepressants or history of psychoactive substance abuse\u002Falcoholism.","65 Years",{"count":260,"type":22},416,[141],"This clinical study investigates whether virtual reality (VR)-based cognitive training can help prevent postoperative delirium (POD) in elderly non-cardiac patients with pre-existing cerebral small vessel disease (CSVD). With the global aging population undergoing more surgical procedures, POD has emerged as a serious complication in surgical patients that can prolong hospital stays and increase the risk of developing Alzheimer's disease. The study utilizes an innovative VR system that combines eye-tracking cognitive assessment with interactive rehabilitation games to evaluate and train patients' cognitive function before non-cardiac and non-intracranial operations. Conducted at Peking University Third Hospital and First Hospital, this research specifically targets patients undergoing general surgery, orthopedic surgery and other non-intracranial\u002Fnon-cardiac procedures to determine if this technology-based intervention can effectively reduce POD incidence in this population while exploring its underlying mechanisms. The findings could lead to a practical solution for protecting cognitive health in elderly patients undergoing routine surgical procedures during recovery",[264,27],"Postoperative Delirium (POD)",[266,267,268,269],"postoperative delirium","cerebral small vascular disease","virtual reality","cognitive function","2025-05-22",{"date":272,"type":42},"2025-05-31",{"date":272,"type":22},{"date":275,"type":22},"2027-12-31",{"name":277,"class":49},"Peking University Third Hospital",2,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":287,"enrollmentInfo":288,"targetDuration":289,"studyType":23,"phases":4,"briefSummary":290,"conditions":291,"keywords":295,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":50},"100528706","dementia-risk-registry-for-young-and-middle-aged-csvd-patients-in-the-next-10-years-100528706","NCT06164262","Dementia Risk Registry for Young and Middle-aged CSVD Patients in the Next 10 Years","Dementia Risk rEgistry for Young And Middle-aged CSVD Patients in the Next 10 Years（DREAM-10）","DREAM-10","Inclusion Criteria:\n\n1. Patients with any of the CSVD-related MRI imaging markers, including recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and superficial cortical siderosis.\n2. Patients aged from 30 to 60 years.\n3. Sign informed consent.\n\nExclusion Criteria:\n\n1. Unable to cooperate with inspectors.\n2. Known dementia.\n3. Other cognitive diseases (such as Alzheimer's disease, Parkinson's disease, or thyroid disease).\n4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness.\n5. Contraindications for imaging examination.\n\nExit Criteria:\n\n1. Not meet the inclusion criteria.\n2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.\n3. Any adverse or serious adverse events during the study period judged by investigator.","60 Years",{"count":21,"type":22},"10 Years","Age-related cerebral small-vessel disease (CSVD) is a major cause of dementia, predominantly affecting individuals over 60 years of age, with a prevalence exceeding 70% in the elderly population. However, the correlation between the burden of CSVD and the progression of cognitive impairment in young and middle-aged individuals remains uncertain. DREAM-10 is an observational, prospective study that enrolled individuals aged 30-60 years, who were free from known dementia but exhibited imaging markers related to CSVD. Through prospective registration and follow-up, this study will collect data on patients with CSVD, including clinical information, neuropsychological assessments, multimodal Magnetic Resonance Images (MRI) and retinopathy characterized by Optical Coherence Tomography Angiography (OCTA). CSVD related features seen on neuroimaging include recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, brain atrophy, cortical superficial siderosis. Utilizing this data, the researchers aim to investigate the potential dementia risk among young and middle-aged individuals with CSVD over the forthcoming decade, along with identifying its predictive factors.",[27,292,293,294],"Dementia, Mixed","Health Behavior","Health Behavior, Risky",[27,296,297],"Dementia","Cardiovascular health","2025-05-18",{"date":300,"type":42},"2025-05-21",{"date":302,"type":42},"2024-01-01",{"date":304,"type":22},"2034-12-01",{"name":306,"class":49},"Zhejiang Provincial People's Hospital",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":315,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":316,"conditions":317,"keywords":321,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":50},"100516897","white-matter-hyperintensity-shape-and-glymphatics-100516897","NCT06010511","WHIte MAtter Hyperintensity Shape and Glymphatics","White Matter Hyperintensity Shape and Glymphatics","WHIMAS","Inclusion Criteria:\n\n* Admitted to the memory or the geriatric clinic of the LUMC, the Alrijne Hospital Leiden or the Haga Hospital the Hague\n* From 65 years of age\n* Eligible for MRI\n* Native-level Dutch speaker\n\nExclusion Criteria:\n\n* Claustrophobia\n* Contraindications for MRI such as metal implants and pacemaker\n* Use of benzodiazepines\n* Initiated treatment with antidepressants less than 6 weeks prior to inclusion\n* Not being able to provide written informed consent (assessed by the treating physician)\n* Individuals that have been declared mentally incapacitated\n* Other severe neurological disease besides dementia related\n* Cognitive impairment due to known other neurological disease\n* Previous brain surgery",{"count":113,"type":22},"In a society with increased life expectancy, the economic, social and personal burden of dementia increases. Dementia is often caused by a combination of neurovascular and neurodegenerative diseases. Impaired brain clearance is suggested to be closely related to dementia development, as waste products (e.g. amyloid beta) accumulate in the brain, leading to neurodegeneration. Cerebral small vessel disease (SVD) is the most common neurovascular disease that even contributes to about 45% of dementia pathophysiology in patients with a diagnosis of Alzheimer's dementia. White matter hyperintensities of presumed vascular origin (WMH) are the key brain MRI manifestation of cerebral SVD. There is evidence that the currently known and MRI-visible WMH are landmarks of an already progressed stage of the underlying pathology. The pathophysiology of WMH has been attributed to multiple underlying mechanisms, such as hypoperfusion, defective cerebrovascular reactivity and blood-brain barrier dysfunction. Furthermore, different anatomical locations and different types of WMH are related to different underlying pathological changes. Using ultra-high field 7T MR imaging techniques WMH lesions can be detected with a higher sensitivity and resolution than on 3T MRI. The hypothesis is that different pathological mechanisms of cerebral SVD lead to variations in WMH shape. Moreover, the brain clearance ('glymphatic') system of the brain appears to be tightly connected to dementia pathology. Thus, novel markers of glymphatic activity could aid to describe and understand the pathology.",[27,292,318,319,117,320],"Dementia, Vascular","Mild Cognitive Impairment","Cognitive Decline",[322,323,324,325,326,327],"dementia","cerebral small vessel disease","White matter hyperintensities","cognitive impairment","cognitive decline","Glymphatics","2025-04-10",{"date":330,"type":42},"2025-04-13",{"date":332,"type":42},"2023-01-18",{"date":334,"type":22},"2027-08-31",{"name":336,"class":49},"Leiden University Medical Center",{"id":338,"slug":339,"hasResults":12,"nctId":340,"briefTitle":341,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":12,"sex":17,"minAge":344,"maxAge":19,"enrollmentInfo":345,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":50},"100518520","revascularization-effect-on-csvd-burden-in-carotid-artery-stenosis-100518520","NCT06031610","Revascularization Effect on CSVD Burden in Carotid Artery Stenosis","RECAS","Inclusion Criteria:\n\n1. Patients aged ≥ 40 years.\n2. ≥ 50% stenosis in unilateral carotid artery.\n3. Sign informed consent.\n\nExclusion Criteria:\n\n1. Previous history of major head trauma and any intracranial surgery\n2. Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage, and other space occupying lesions\n3. Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement.\n4. Severe loss of vision, hearing, or communicative ability.","40 Years",{"count":21,"type":22},"RECAS is a prospective cohort of 1,000 patients with carotid artery stenosis (CAS) and undergoing revascularization therapy or standard medication treatment alone. The goal of this study is to validate whether CAS revascularization when compared to standard medication treatment alone, can effectively reduce the progression of Cerebral small vessel disease (CSVD) burden, as well as improve the severity of retinal pathologies and cognitive impairment. Therefore, Patients aged ≥ 40 years have more than 50% stenosis in unilateral carotid artery and sign informed consent will be recruited. In this study, patients will be asked to undergo Computed Tomography Angiography (CTA)\u002F Digital Subtraction Angiography (DSA), Computed Tomography Perfusion (CTP),multimodal Magnetic Resonance Imaging (MRI), Optical Coherence Tomography Angiography (OCTA) and neuropsychological testing. Estimated follow-up can be up to 10 years.",[348,27],"Carotid Artery Stenosis",[348,27,350,351,352],"Revascularization","Carotid artery stenting","prospective cohort","2025-02-10",{"date":355,"type":42},"2025-02-12",{"date":357,"type":42},"2023-06-10",{"date":359,"type":22},"2034-05",{"name":306,"class":49},{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":367,"eligibilityCriteria":368,"healthyVolunteers":82,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":369,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":278},"100560632","prospective-observation-on-cerebral-microvascular-structure-and-function-100560632","NCT06579677","PRospective Observation on CErebral microvaScular Structure and Function","PRospective Observation on CErebral microvaScular Structure and Function (PROCESS): a Population-based Prospective Cohort Study","PROCESS","Inclusion Criteria:\n\n1. Community-dwelling adults aged 50-75 years;\n2. Registered Beijing household residents or residents who can be followed up stably in their own communities for a long period;\n3. Subjects with written informed consents.\n\nExclusion Criteria:\n\n1. Residents with moderate to severe disabilities (MRS ≥3), mental illness, stroke, dementia, and other serious neurological disorders (e.g., encephalitis, Parkinson's disease, epilepsy, brain tumors, and rare genetic diseases of the nervous system);\n2. Life expectancy of ≤4 years due to serious diseases such as end-stage cancer;\n3. Contraindications to magnetic resonance imaging such as implanted devices (e.g., pacemakers, defibrillators, and others);\n4. Residents who are participating in other studies.",{"count":370,"type":22},3500,"This is a population-based prospective cohort study, aiming to assess the prevalence, distributional characteristics, and dynamic change of cerebral small vessel dysfunction in a Chinese community population using advanced vascular imaging techniques; meanwhile to investigate the effect of vascular risk factors on cerebral small vessel dysfunction, cardiovascular and cerebrovascular diseases, cognitive dysfunction, and mortality.",[373,27,374,375,376,377],"Cerebral Microvascular Dysfunction","Cognitive Dysfunction","Cerebrovascular Disorders","Cardiovascular Diseases","Population","2025-01-02",{"date":380,"type":42},"2025-01-06",{"date":382,"type":42},"2024-10-18",{"date":384,"type":22},"2032-10",{"name":177,"class":49},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":4,"eligibilityCriteria":392,"healthyVolunteers":82,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":393,"targetDuration":4,"studyType":139,"phases":395,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":278},"100552547","efficacy-and-safety-of-calculus-bovis-sativus-cbs-for-ischemic-cerebral-vascular-disease-cbsinicvd-100552547","NCT06474507","Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease (CBSinICVD)","An Open Label Clinical Trial to Evaluate the Efficacy and Safety of Calculus Bovis Sativus (CBS) for Ischemic Cerebral Vascular Disease","Inclusion Criteria:\n\n* ICVD cohort:\n\n  * Subjects are able to understand the purpose and risks of the study, provide informed consent, and authorize the use of confidential health information in accordance with national and local privacy regulations.\n  * Both men and women are welcome, and the age at the time of providing informed consent is 18-80 years (inclusive).\n  * All women of childbearing age and all men must use contraceptive measures during the study and for at least 30 days after the last dose of study treatment. In addition, subjects should not donate sperm or eggs during the study and for at least 30 days after the last dose of study treatment.\n  * Must be diagnosed with\n\n    ① Ischemic stroke, according to the \"Diagnosis Points of Various Cerebrovascular Diseases\" of the Fourth National Cerebrovascular Disease Academic Conference, the main clinical diagnosis is ischemic stroke (cerebral infarction), 1 point ≤ NIHSS ≤ 24 points, and mRS ≤ 3 points; or ② Cerebral small vessel disease, according to the results of conventional sequence MRI examination, Fazekas score on T2 FLAIR sequence ≥ 3 points (0-6 points, the sum of paraventricular WMH score + subcortical WMH score), and mRS ≤ 3 points (mRS ≤ 4 points for those with recent subcortical small infarction within 1 month).\n  * Neurological examination showed stability within 30 days before baseline (visit 1).\n* Healthy cohort:\n\n  * Age ≥ 18 years old when signing the informed consent form\n  * Healthy adult subjects without underlying diseases\n\nExclusion Criteria:\n\n1. Medical History and Current Health Status 1.1. Any clinically significant cardiac, endocrine, hematologic, hepatic, immune, infectious, metabolic, urologic, pulmonary, neurological, dermatologic, psychiatric, and renal disease or other major medical history that the investigator determines would preclude participation in the clinical trial.\n\n   1.2. Any untreated teratoma or thymoma at the baseline visit (randomization) 1.3. Other causes of symptoms, including CNS infection, septic encephalopathy, metabolic encephalopathy, epileptic disorders, mitochondrial disease, Klein-Levin syndrome, Creutzfeldt-Jakob disease, rheumatic disease, Reyes syndrome, or inborn errors of metabolism.\n\n   1.4. History of herpes simplex encephalitis within the previous 24 weeks. 1.5. Any surgical procedure within 4 weeks prior to baseline, except laparoscopic surgery or minor surgery (defined as surgery requiring only local anesthesia or conscious sedation, i.e., surgery that does not require general, neuraxial, or regional anesthesia and can be performed on an outpatient basis; e.g., toenail surgery, mole surgery, wisdom tooth extraction), excluding thymoma or teratoma removal.\n\n   1.6. Planned surgery during the study (except minor surgery). 1.7. History of severe allergic or anaphylactic reactions, or any allergic reaction that the investigator believes may be exacerbated by any component of study treatment.\n\n   1.8. Current or history of malignant disease, including solid tumors and hematologic malignancies (except for basal cell carcinoma and squamous cell carcinoma that have been completely resected and considered cured for at least 12 months prior to Day -1). Subjects with cancer remission for more than 5 years prior to baseline (Visit 1) may be included after discussion with the sponsor\u002Fsponsor approval.\n\n   1.9. A history of gastrointestinal surgery (except appendectomy or cholecystectomy performed more than 6 months before screening), irritable bowel syndrome, inflammatory bowel disease (Crohn's disease, ulcerative colitis), or other clinically significant active gastrointestinal diseases in the opinion of the investigator.\n\n   1.10. A history of clinically significant recurrent or active gastrointestinal symptoms (e.g., nausea, diarrhea, dyspepsia, constipation) within 90 days before screening, including the need to start symptomatic treatment (e.g., start medication for gastroesophageal reflux disease) or a change in symptomatic treatment within 90 days before screening (e.g., dose increase).\n\n   1.11. A history of diverticulitis or concurrent severe gastrointestinal (GI) abnormalities (e.g., symptomatic diverticular disease) because the investigator believes that this may lead to an increased risk of complications such as GI perforation.\n\n   1.12. A history of blood donation (1 unit or more), plasma donation, or platelet donation within 90 days before screening.\n\n   1.13. Active suicidal ideation within 6 months before screening, or a history of suicide attempt within 3 years before screening.\n\n   1.14. Based on the investigator's judgment, there are serious diseases or abnormalities in the clinical laboratory test results that prevent the patient from completing the study or participating in the study safely.\n\n   1.15. Pregnant or lactating, or planning to become pregnant during the study or within 3 months after the last dose of the study drug; women of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result before the start of the study.\n\n   1.16. The subject's mental or physical condition will hinder the evaluation of efficacy and safety.\n\n   1.17. Systolic blood pressure \\>150 mmHg or \\\u003C90 mmHg after sitting still for 5 minutes or before dosing at screening. If out of range, it can be measured again at screening and before dosing. If the repeated measurement value is still out of range, the subject shall not receive the drug.\n\n   1.18. Subjects with second or third degree atrioventricular block or sick sinus syndrome, poorly controlled atrial fibrillation, severe or unstable angina, congestive heart failure, myocardial infarction, or significant ECG abnormalities, including QTc\\>450 msec (male) or 470 msec (female), where QTc is determined based on the Fridericia correction method, within 3 months prior to the screening visit.\n\n   1.19. Planned elective procedures or surgeries at any time after signing the ICF by follow-up visit.\n\n   1.20. Any condition that affects the absorption of study treatment (e.g., gastrectomy).\n\n   1.21. History of hypersensitivity to heparin or history of heparin-induced thrombocytopenia.\n\n   1.22. Subjects with abnormalities in medical history, physical examination, ECG, or diagnostic laboratory tests that the investigator considers to be clinically relevant.\n2. Risk of infection 2.1. History of human immunodeficiency virus (HIV) or positive test results at screening.\n\n   2.2. Current infection with hepatitis C (defined as positive HCV antibodies and detectable HCV RNA). Subjects with positive HCV antibodies and HCV RNA below the limit of detection are eligible to participate in the study.\n\n   2.3. Current infection with hepatitis B (defined as positive HBsAg and\u002For positive total anti-HBc). Subjects who are immune to hepatitis B after previous natural infection (defined as negative HBsAg, positive anti-HBc, and positive anti-HBs) or vaccination (defined as negative HBsAg, negative anti-HBc, and positive anti-HBs) are eligible to participate in the study.\n\n   2.4. Chronic, recurrent, or severe infection (e.g., pneumonia, sepsis) within 90 days prior to baseline (visit 1).\n\n   2.5. History of TB diagnosis or positive latent TB test result (defined as positive IGRA test result or 2 consecutive times.\n\n   2.6. Symptoms of bacterial, fungal, or viral infection (including upper respiratory tract infection) within 28 days prior to baseline (visit 1). Subjects with localized fungal infection (e.g., candidiasis, tinea) are eligible for rescreening after successful treatment of the infection.\n\n   2.7. Infection requiring hospitalization or IV anti-infective medication within 4 weeks prior to baseline visit.\n\n   2.8. Any live or live attenuated vaccine within 28 days prior to baseline (visit 1) or planned during the study.\n\n   2.9. Contraindications to all of the following salvage therapies: rituximab, IVIG, high-dose corticosteroids, or IV cyclophosphamide.\n\n   2.10. History of or receipt of the following treatments:\n   1. Total lymphoid irradiation, cladribine, T-cell or T Cell recipient vaccination, total body irradiation, or total lymphoid irradiation at any time.\n   2. Stem cell transplantation at any time.\n3. Laboratory Values 3.1. Abnormal laboratory values determined by the investigator to be clinically significant at Screening or Baseline (Visit 1).\n\n   3.2. Any of the following blood test abnormalities at Screening:\n   1. WBC \\\u003C 3.0 × 103\u002FµL\n   2. ANC \\\u003C 2.0 × 103\u002FµL\n   3. Absolute lymphocyte count \\\u003C 0.5 × 103\u002FµL\n   4. Platelet count \\\u003C × 10 × 104\u002FµL\n   5. ALT, AST, or GGT ≥ 3 x ULN or bilirubin \\> 2 x ULN\n   6. eGFR ≤ 60 mL\u002Fmin\u002F1.73 m2\n   7. Lymphocyte count \\\u003C LLN 3.3. Any of the following urine test abnormalities at Screening:\n\n   \u003C!-- -->\n\n   1. β-2-microglobulin\\>0.3 μg\u002FmL\n   2. Albumin\u002Fcreatinine ratio\\>22.6 mg\u002Fmmol\n4. Others 4.1. Previous participation in this study. 4.2. Blood donation (1 unit or more) within 90 days before screening, plasma donation within 1 week before screening, and platelet donation within 6 weeks before screening.\n\n4.3. History of alcohol or drug abuse in the past year (determined by the investigator).\n\n4.4. Pregnant or lactating subjects, as well as subjects planning to become pregnant or start breastfeeding at any time during the study and within 30 days after completion of study treatment.\n\n4.5. Participating in a clinical trial or having participated in a clinical trial within 90 days before screening.\n\n4.6. History of clinically significant suicidal thoughts or behaviors in the past 12 months as assessed by C-SSRS at screening.\n\n4.7. Unwilling or unable to comply with protocol requirements. 4.8. The patient has obvious hearing or vision impairment, language barriers, claustrophobia, etc., which makes the patient unable to cooperate with the neuropsychological scale assessment and MRI examination.\n\n4.9. The researcher or sponsor believes that there are other unknown reasons that make the subject unsuitable for inclusion.",{"count":394,"type":22},230,[141],"The most common cause of death for Chinese patients is ischemic cerebrovascular diseases(ICVD), particularly cerebral infarction. It places a heavy burden on people, families, and society as a whole and poses considerable risks of death and disability. The disease known as CSVD has a subtle beginning, is difficult to identify, and is frequently detected only after it progresses to the point of vascular cognitive dysfunction. The primary ischemia necrosis of brain nerve cells and the activation of inflammatory cells are their pathologic processes.\n\nAccording to historical Chinese medical documents, bezoar possesses properties that can help prevent seizures, treat strokes, enhance cognitive function and mental well-being, and stimulate alertness. Calculus Bovis Sativus (CBS) is the most authentic formulation of bezoar ingredients compared to other bezoar products. It has received approval from the China Food and Drug Administration for the essential treatment of comatose patients. CBS consists of three primary constituents: bilirubin, bile acids, and taurine. Scientific evidence has demonstrated that all of these components possess anti-inflammatory, antioxidant, and neuroprotective properties.\n\nThe investigators' objective is to carry out an investigator-initiated clinical study to assess the efficacy of orally administered CBS in treating ischemic cerebrovascular diseases in humans.",[398,399,27],"Ischemic Cerebrovascular Disease","Acute Ischemic Stroke",[401,402,403],"Calculus Bovis Sativus","Neuroprotection","Neuroinflammation","2024-09-19",{"date":406,"type":42},"2024-09-20",{"date":408,"type":42},"2024-08-08",{"date":410,"type":22},"2029-12",{"name":412,"class":49},"Tongji Hospital",{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":160,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":434,"locationsCount":50},"100491321","feedback-loop-between-intracranial-atherosclerosis-and-cerebral-small-vessel-disease-100491321","NCT05677607","Feedback Loop Between Intracranial Atherosclerosis and Cerebral Small Vessel Disease","Inclusion Criteria:\n\n* Age ≥ 18 years\n* At least one intracranial artery ≥ 50% atherosclerotic stenosis\n* Modified Rankin Scale \\\u003C 2\n* Mini-mental State Examination \\> 24\n\nExclusion Criteria:\n\n* Concurrent ipsilateral extracranial artery ≥ 50% stenosis\n* Pregnant women\n* Contraindications to magnetic resonance examination (patients with pacemakers, nerve stimulators, artificial metal heart valves and other metal foreign bodies)",{"count":420,"type":22},300,"The present study aims at verifying the mutual effects between intracranial large artery atherosclerosis and cerebral small vessel disease on disease progression and prognosis by magnetic resonance imaging, and providing biomarkers for the early prevention and treatment of cerebrovascular disease.",[423,27],"ICAS - Intracranial Atherosclerosis",[425,194,426,427],"Intracranial atherosclerosis","Feedback mechanism","Multimodal MRI","2024-06-30",{"date":430,"type":42},"2024-07-03",{"date":432,"type":42},"2023-01-01",{"date":275,"type":22},{"name":435,"class":49},"Chinese PLA General Hospital",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":443,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":50},"100549261","fundus-optical-coherence-tomography-angiography-evaluation-for-small-vessel-health-in-cerebral-small-vessel-disease-100549261","NCT06431711","Fundus Optical coheRence Tomography Angiography Evaluation for Small-vessel Health in Cerebral Small Vessel Disease","FRESH-CSVD","Inclusion Criteria:\n\n1. Older than 35 years old;\n2. Patients who underwent Multimodal MRI with any CSVD imaging marker;\n3. Subjects who have signed informed consent.\n\nExclusion Criteria:\n\n1. Patient who was unable to cooperate with examinations;\n2. There are known diseases that may cause or worsen CSVD (brain injury, Down syndrome, Alzheimer's disease, Parkinson's disease, etc.);\n3. There are known eye diseases or severe underlying fundus lesions that may impact fundus assessment;\n4. Suffering from serious systemic diseases, such as heart, liver, kidney diseases or major mental illnesses;\n5. Contraindications for imaging examinations\n\nExit Criteria:\n\n1. Not meet the inclusion criteria.\n2. For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator.\n3. Any adverse or serious adverse events during the study period judged by investigator","35 Years",{"count":445,"type":22},2400,"Cerebral small-vessel disease (CSVD) is a significant contributor to stroke and dementia, primarily impacting individuals over the age of 60. Its prevalence exceeds 70% in the elderly population, imposing a substantial burden on brain health and the economy. Optical coherence tomography angiography (OCTA) is a new type of optical diagnostic imaging technology for non-invasive detection, which can perform multi-dimensional quantitative assessment of fundus retinopathy. Current studies have shown that fundus OCTA-derived parameters may have potential in characterizing imaging changes in CSVD. However, the correlation between retinal\u002Fchoroidal parameters on OCTA and the CSVD imaging markers remains uncertain. FRESH-CSVD is a prospective, observational study that will use fundus OCTA-derived parameters to screen patients with CSVD, explore the relationship between relevant parameters based on OCTA measurements and CSVD, and evaluate the feasibility and clinical value of identification of CSVD through fundus OCTA.",[27,448,449],"Retinal Ischemia","Choroid; Injury","2024-05-27",{"date":452,"type":42},"2024-05-29",{"date":454,"type":42},"2024-04-01",{"date":456,"type":22},"2034-03-31",{"name":306,"class":49},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":139,"phases":468,"briefSummary":469,"conditions":470,"keywords":471,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":484,"lastUpdatePostDateStruct":485,"startDateStruct":487,"completionDateStruct":489,"leadSponsor":491,"locationsCount":278},"100462834","stopping-cognitive-decline-and-dementia-by-fighting-covert-cerebral-small-vessel-disease-100462834","NCT05306834","Stopping Cognitive Decline and Dementia by Fighting Covert Cerebral Small Vessel Disease","SHIVA","Inclusion Criteria:\n\nFor the extensive cSVD patient group\n\n1. For the extensive cSVD patient group included in the LEOPOLD trial:\n\n   * Patients aged 60 to 88 years,\n   * Patients included in the LEOPOLD trial and having performed their brain MRI on SIEMENS PRISMA machine\n   * Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n   * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study).\n2. For the extensive cSVD patient group not included in the LEOPOLD trial:\n\n   * Patients aged 60 to 88 years,\n   * Patients with a cognitive complaint MMSE ≥ 20 performed in the 6 months before inclusion, associated or not with impaired cognitive tests and\u002For diaognosis of incipient dementia without pronounced cognitive deterioration,\n   * Patients with a socio-educational level ≥ 3,\n   * Patients with a moderate to high grade of hypersignals on an MRI OR on an CT scan performed prior inclusion (grades C and D of the modified Scheltens scale or grade 2\u002F3 Fazekas),\n   * Arterial hypertension defined by a Systolic Blood Pressure (SBP) and \u002F or Diastolic Blood Pressure (DBP) ≥ 140\u002F90 mmHg (according to the definition of the national health authority \\[HAS\\]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion.\n   * Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n   * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study)\n\nFor the minimal cSVD patient group:\n\n* Patients aged 60 to 88 years,\n* Patients with a cognitive complaint (MMSE ≥ 20 performed at the SHIVA inclusion visit or in the 6 monts prior the visit) associated or not with impaired cognitive tests and\u002For diagnosis of incipient dementia without pronounced cognitive deterioration,\n* Patients with little or no white matter hypertensities on brain MRI (grades 0 or 1 on the Fazekas scale); without lacunes or microbleeds,\n* Arterial hypertension defined by a Systolic Blood Pressure (SBP) and \u002F or Diastolic Blood Pressure (DBP) ≥ 140\u002F90 mmHg (according to the definition of the national health authority \\[HAS\\]), treated or not, confirmed within the previous 12 months or at the latest on the day of inclusion. Blood pressure values for this inclusion criterion can be objectified by several self-measurements performed by the patient at home for 3 days in a sitting or lying position (3 measurements on sitting or lying position and 3 measurements in standing position).\n* Being affiliated or beneficiary of the French national health insurance (\"sécurité sociale\"),\n* Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research study\n\nExclusion Criteria:\n\nFor Extensive cSVD patient group :\n\n1. For the extensive cSVD patient group also included in the LEOPOLD trial:\n\n   * patients with severe myopia greater than -6 dioptres\n   * partients with known allergy to Tropicamide (Mydriaticum®)\n   * patients with an extensive cataract\n   * patients with ptosis\n2. For the extensive cSVD patient group not included in the LEOPOLD trial:\n\n   * Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and \u002F or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,\n   * Very severe renal impairment (creatinine clearance less than 15 ml \u002F min) on a blood test dating back less than one year,\n   * Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...\n   * Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),\n   * Associated severe diseases, with a life expectancy of less than 3 months,\n   * Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),\n   * Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia\n   * Persons under tutorship or curatorship,\n   * Patients with loss of autonomy living in EHPAD (nursing home)\n   * patients with severe myopia greater than -6 dioptres\n   * participants with known allergy to Tropicamide (Mydriaticum®)\n   * patients with an extensive cataract\n   * patients with ptosis\n\nFor the minimal cSVD patient group:\n\n* Orthostatic hypotension defined by a decrease of 20 mmHg in SBP and \u002F or 10 mmHg in DBP in a standing position at 3 minutes sought in the previous 3 months or on the day of inclusion,\n* Very severe renal impairment (creatinine clearance less than 15 ml \u002F min) on a blood test dating back less than one year,\n* Secondary hypertension: renovascular hypertension, primary hyperaldosteronism, pheochromocytoma...\n* Contraindication to MRI (presence of a ferromagnetic foreign body, in particular certain intracranial clips, certain heart valves, an intraocular foreign body, metal prosthesis, subject carrying a pacemaker, subject carrying prosthetic heart valves incompatible with MRI. ventricular shunt, claustrophobia),\n* Associated severe diseases, with a life expectancy of less than 3 months,\n* Physical problems likely to interfere with the feasibility of the tests (sight, hearing, etc.),\n* Existence of dementia of which the etiology is distinct from Alzheimer's disease, vascular or mixed dementia\n* Persons under tutorship or curatorship,\n* Patients with loss of autonomy living in EHPAD (nursing home)\n* Patients with severe myopia greater than -6 dioptries\n* Patients with known allergy to Tropicamide (Mydriaticum®)\n* Patients with an extensive cataract\n* Patients with ptosis","88 Years",{"count":467,"type":22},400,[141],"Cerebral small Vessel Disease (cSVD), characterized by an alteration of the structure and function of small penetrating brain arteries, is highly prevalent in older persons from the general population and represents a leading cause of stroke and a major contributor to cognitive decline and dementia risk. In France \\>4 million persons aged 60+ are estimated to have moderate to extensive covert cSVD (ccSVD), i.e. features of SVD on brain imaging without a history of clinical stroke. Better detection and management of covert cSVD would have a major impact on preventing disability and costs related to stroke, cognitive impairment and dementia. However, there are no specific mechanistic treatments for cSVD and hardly any recommendations worldwide on how to prevent and treat cSVD and related cognitive impairment. The aim of the present study, through the identification of novel cutting-edge multimodal biomarkers, is to develop innovative diagnostic and risk prediction tools for cSVD and its complications and to contribute to accelerating the discovery of novel drug targets and therapeutics strategies for cSVD.",[27,94,296],[472,296,94,473,474,475,476,477,478,479,480,481,482,483],"Cognitive decline","Small vessel disease","Healthy brain aging","Brain imaging","Adaptive optics","Optical coherence tomography angiography","Prevention","Risk prediction","Genomic","Multiomics","Proteomics","Metabolomics","2024-01-25",{"date":486,"type":42},"2024-01-26",{"date":488,"type":42},"2022-11-10",{"date":490,"type":22},"2027-11",{"name":492,"class":49},"University Hospital, Bordeaux",{"id":494,"slug":495,"hasResults":12,"nctId":496,"briefTitle":497,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":516,"locationsCount":50},"100522031","a-registry-study-of-microcirculation-disorder-after-cerebral-small-vessel-disease-and-ischemic-stroke-100522031","NCT06077305","A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke","A Registry Study of Microcirculation Disorder After Cerebral Small Vessel Disease and Ischemic Stroke, MODEST, Research Protocol","MODEST","Inclusion Criteria:\n\nStudy 1:\n\n1. Age ≥ 18 years old.\n2. Acute ischemic stroke within 7 days of onset.\n3. Sign an informed consent form.\n\nStudy 2:\n\n1. Age ≥ 18 years old.\n2. Ischemic stroke during recovery period, within 30 days to 1 year of onset.\n3. Sign an informed consent form.\n\nStudy 3:\n\n1. Age ≥ 18 years old.\n2. Within 3 years, there are characteristic lesions of cerebral small vessel disease on head MRI or CT, and they meet at least one of the following criteria:\n\n   1. Paraventricular or deep white matter hyperintensities, Fazekas total score ≥ 2;\n   2. Paraventricular or deep white matter hyperintensities, Fazekas total score=1, and at least two vascular risk factors (hypertension, hyperlipidemia, diabetes, current smoking, obesity, history of coronary heart disease, history of stroke).\n   3. Paraventricular or deep white matter hyperintensities, Fazekas total score=1, with ≥ 1 lacune.\n   4. New recent subcortical small infarcts.\n3. Sign an informed consent form.\n\nExclusion Criteria:\n\nStudy 1:\n\n1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.\n2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\\>3mm).\n3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.\n4. A mental illness diagnosed according to the DSM-V diagnostic criteria.\n5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.\n6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.\n7. The patient also participated in other clinical trials.\n\nStudy 2:\n\n1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.\n2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\\>3mm).\n3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.\n4. A mental illness diagnosed according to the DSM-V diagnostic criteria.\n5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.\n6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.\n7. The patient also participated in other clinical trials.\n\nStudy 3:\n\n1. Cerebral hemorrhage and subarachnoid hemorrhage within 3 months of onset.\n2. There are untreated cerebral vascular malformations or untreated aneurysms (diameter\\>3mm).\n3. Confirmed neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, Parkinson's syndrome, etc.\n4. A mental illness diagnosed according to the DSM-V diagnostic criteria.\n5. There are clear diagnoses of non-vascular white matter lesions, such as multiple sclerosis, adult white matter dysplasia, metabolic encephalopathy, etc.\n6. Unable to cooperate in completing follow-up visits due to geographical or other reasons.\n7. The patient also participated in other clinical trials.",{"count":502,"type":22},20000,"This study aims to construct a registry platform for microcirculatory disorders in a large sample of Chinese patients with cerebral small vessel disease and ischemic stroke; To explore the role of microcirculatory disorders in different types of cerebral small vessel disease and iachemic stroke, as well as their pathogenesis, severity, and prognosis; And to research on the drug treatment of microcirculatory disorders for cerebral small vessel disease and stroke in the real world.",[27,505],"Ischemic Stroke",[27,505,507,508,509],"Microcirculation Disorder","Multicenter Study","Registry Study","2023-10-18",{"date":512,"type":42},"2023-10-19",{"date":514,"type":22},"2023-10-30",{"date":124,"type":22},{"name":177,"class":49},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":58,"maxAge":523,"enrollmentInfo":524,"targetDuration":160,"studyType":23,"phases":4,"briefSummary":526,"conditions":527,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":528,"lastUpdatePostDateStruct":529,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":50},"100386929","cerebral-small-vessel-disease-registry-study-100386929","NCT04318119","Cerebral Small Vessel Disease Registry Study","Inclusion Criteria:\n\n1. Sign informed consent.\n2. Age\\>18\n3. At least one of the following CSVD MRI characteristics: ①recent small subcortical infarct;②lacune of presumed vascular origin;③white matter hypertensity of presumed vascular origin;④perivascular space;⑤cerebral microbleeds;⑥brain atrophy\n\nExclusion Criteria:\n\n1. Unable to cooperate with inspectors\n2. Non-vascular white matter lesions\n3. Other cognitive diseases (such as alzheimer's disease, Parkinson's disease or thyroid disease)\n4. Serious systemic illness, such as heart, liver, kidney disease or major mental illness\n5. Contraindications for imaging examination","100 Years",{"count":525,"type":22},3000,"The aim of this study is to determine the clinical spectrum and natural progression of Cerebral Small Vessel Disease (CSVD) and in a prospective multicenter study, to assess the clinical, genetic and epigenetic features of patients with CSVD, , to find independent imaging markers, and to optimize clinical management.",[27],"2023-09-26",{"date":530,"type":42},"2023-09-28",{"date":532,"type":42},"2019-11-18",{"date":534,"type":22},"2055-11-18",{"name":536,"class":49},"Bin Cai",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":544,"targetDuration":4,"studyType":139,"phases":546,"briefSummary":548,"conditions":549,"keywords":550,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":552,"lastUpdatePostDateStruct":553,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":4},"100520832","phase-4-tongxinluo-capsule-in-the-treatment-of-cerebral-small-vessel-disease-a-randomized-double-blind-placebo-controlled-multicenter-clinical-studytops-csvd-100520832","NCT06061692","Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study（TOPS-CSVD）","Tongxinluo Capsule in the Treatment of Cerebral Small Vessel Disease-A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study (TOPS-CSVD)","Inclusion Criteria:\n\n1. Age 50-80 years (both inclusive);\n2. Complaints of cognitive impairment involving memory and\u002For other cognitive domains for at least 3 months;\n3. Neither normal nor demented cognitive level according to DSM-V criteria, MMSE scale score ≥20 (elementary school) or ≥24 (junior high school and above); CDR scale score ≥0.5 in at least one domain and overall CDR score ≤1;\n4. MRI has: ① moderate to severe white matter lesions (deep Fazekas score \\> 1 or paraventricular Fazekas score \\> 2); Mild white matter hyperintensity (deep Fazekas score = 1 or paraventricular Fazekas score = 2) combined with more than 1 lacunar infarction or more than 3 microbleeds foci. ② Absence of old cortical or watershed infarction, cerebral hemorrhage, hydrocephalus, and other cerebral white matter lesions of definite etiology (e.g., multiple sclerosis, metabolic, toxic, etc.);\n5. Voluntary participation in the study and willing to sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Previously diagnosed with dementia;\n2. Acute stroke event within 6 months;\n3. Previously diagnosed hereditary or inflammatory small vessel disease;\n4. Presence of congenital mental retardation and severe neurological and psychiatric diseases;\n5. Illiterate or severe visual or hearing impairment that may prevent patients from cooperating with neuropsychological assessment;\n6. Relevant depression (Hamilton Depression Scale score ≥ 17 points), or other unrelated serious mental illness (schizophrenia, bipolar disorder or delirium);\n7. Combined with severe cardiac, pulmonary and renal insufficiency (creatinine \\> 2.0 mg\u002FdL or 177 μmol\u002FL), severe hepatic impairment (transaminase more than 3 times of normal value);\n8. Alcohol abuse, drug abuse or use of drugs affecting cognitive assessment, such as sedatives, hypnotics, nootropic drugs, cholinergic drugs;\n9. Definitely diagnosed malignant tumor, vital organ failure;\n10. Previous allergy or intolerance to Tongxinluo ingredients;\n11. The subject has no stable and reliable caregiver, or the caregiver is unable to help the subject participate in the whole process of the study;\n12. Patients who have participated in other interventional clinical studies within the last 3 months, or are participating in other interventional clinical studies.",{"count":545,"type":22},1052,[547],"PHASE4","Cerebral small vessel disease is a series of clinical, imaging and pathological syndromes caused by various etiologies affecting the arteries, capillaries, venules in the brain. The common causes of cerebral small vessel disease include arteriolosclerosis, cerebral amyloid angiopathy, hereditary cerebral small vessel disease, inflammation-and immune-mediated small vessel disease, venous collagen disease and other small vessel diseases. Of these, age-and hypertension-related cerebral small vessel disease and amyloidosis cerebral small vessel disease are the most common types. The pathophysiological mechanism and clinical manifestations of cerebral small vessel disease are complex. One-fifth of ischemic strokes and the vast majority of nontraumatic parenchymal hemorrhages are due to cerebral small vessel disease. In addition to stroke, patients with cerebral small vessel disease are more often characterized by chronic progressive neurological impairment, which is an important cause of cognitive decline and functional disability in the elderly, and has become one of the important public health problems affecting the quality of life of the elderly.\n\nFocusing on cognitive impairment-related diseases, a large number of clinical studies have shown that Tongxinluo capsule has a dual neurovascular protective effect, which can increase the Mini-Mental State Examination (MMSE) score and activities of daily living (ADL) score of patients with lacunar cerebral infarction combined with vascular cognitive impairment, reduce fibrinogen (FIB) concentration, improve whole blood viscosity, improve blood viscosity and FIB level, improve activities of daily living and accelerate intellectual recovery in patients with VD; It can also reduce the levels of ET-1 and homocysteine in AD patients, reduce the whole blood viscosity and thus improve the microcirculation in the elderly, increase cerebral blood flow, increase the scores of MMSE and ADL, improve the intelligence of patients, improve memory disorders and language disorders. Meta-analysis of 3458 patients in 40 published clinical literatures of Tongxinluo capsule both domestically and internationally confirmed that Tongxinluo capsule had the effect of promoting the recovery of neurological function, and was safe without adverse reactions.\n\nThis project is a randomized, double-blind, placebo-controlled multicenter clinical study to investigate the clinical efficacy and safety of Tongxinluo capsule in the treatment of cerebral small vessel disease. A total of 1052 subjects who met the subject screening criteria are planned to be enrolled, with 526 patients in the test group and 526 patients in the placebo group.\n\nThe study is conducted using a central randomization method. For the patients who met the inclusion criteria after examination, they are logged into the Interactive Web Response System by their site, entered the relevant information, and randomized and assigned drugs automatically by the central server according to the ratio of 1:1. Once enrolled, all patients receive the study drug (Tongxinluo or placebo) at 4 capsules\u002Ftid for up to 12 months. The study is planned to be conducted at approximately 50 centers across the country using central randomized competing enrollment.",[27],[551],"Cerebral Small Vessel Diseases, cognitive impairment","2023-09-25",{"date":554,"type":42},"2023-09-29",{"date":556,"type":22},"2023-10",{"date":558,"type":22},"2026-12",{"name":560,"class":49},"Fudan University",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":565,"acronym":4,"eligibilityCriteria":566,"healthyVolunteers":82,"sex":17,"minAge":58,"maxAge":19,"enrollmentInfo":567,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":569,"conditions":570,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":577,"locationsCount":50},"100514954","cohort-study-of-inpatients-and-outpatient-patients-with-cerebral-small-vessel-disease-100514954","NCT05985213","Cohort Study of Inpatients and Outpatient Patients With Cerebral Small Vessel Disease","Inclusion Criteria:\n\n1. Participants aged between 18 and 80 years, with no restriction on gender.\n2. Participants who have completed a 3.0T MRI of the head within one year at Yueyang Hospital, and meet the imaging diagnostic criteria of the 2013 STRIVE guidelines.\n3. Participants who have a Modified Rankin Scale (mRS) score of 0-2 (able to perform activities of daily living) at the time of the visit.\n4. Participants who are able to understand and agree to participate in the study, and have signed the informed consent form.\n\nExclusion Criteria:\n\n1. Diagnosis of symptomatic lacunar syndrome without 6 months of onset (participants can be enrolled after 6 months to avoid the impact of the acute phase).\n2. Intracranial and extracranial vascular examination confirms stenosis of the blood vessel by ≥50%.\n3. Imaging data reveals intracranial space-occupying lesions.\n4. A history of other neurological or mental illnesses with a definite diagnosis of the cause, including stroke (excluding lacunar infarctions), neurodegenerative diseases (such as Parkinson's disease and Alzheimer's disease).\n5. Co-occurring serious illnesses, such as malignant tumors, heart failure, respiratory failure, renal failure, severe liver dysfunction, severe blood system diseases, or gastrointestinal bleeding.\n6. Severe impairment in vision, hearing, language function, or limb muscular weakness that prevents completion of relevant tests.\n7. Women who are pregnant or breastfeeding.\n8. MRI scan contraindicated due to various reasons (such as claustrophobia).\n9. Any other reasons that prevent the collection of clinical data required for this study.",{"count":568,"type":22},1078,"This cohort study involves the dynamic collection of clinical information, including serum parameters , blood pressure variability, imaging data, and neuropsychological scales, in patients with cerebral small vessel disease (CSVD). The study aims to summarise the clinical and imaging characteristics of the CSVD population and identify novel CSVD risk factors. Additionally, this study intend to uncover the mechanisms underlying the clinical and imaging outcomes of CSVD. Furthermore, a multivariable prediction model for cognitive and mood disorders in patients with CSVD will be established.",[27],"2023-08-09",{"date":573,"type":42},"2023-08-14",{"date":575,"type":42},"2020-12-01",{"date":101,"type":22},{"name":578,"class":49},"Shanghai Yueyang Integrated Medicine Hospital",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":583,"acronym":584,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":344,"maxAge":4,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":588,"conditions":589,"keywords":591,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":597,"lastUpdatePostDateStruct":598,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":278},"100496591","inflammation-and-small-vessel-disease-study-100496591","NCT05746221","INflammation and Small Vessel Disease Study","INSVD","Inclusion Criteria:\n\n* Have given written informed consent to participate\n* Be aged 40 years and over\n* Have symptomatic cerebral small vessel disease (SVD) defined as:\n* Clinical lacunar stroke syndrome with lacunar infarct, as defined by the Standards for Reporting Vascular Changes on Neuroimaging (STRIVE) criteria\n* And\u002FOR Symptoms of cognitive impairment due to SVD with lacunar infarct on MRI\n* And\u002FOR Gait apraxia\u002Fmotor impairment presumed due to SVD with lacunar infarct on MRI\n\nExclusion Criteria:\n\n* Unable\u002Funwilling to consent including lack of capacity to consent\n* Contraindications to taking part in MRI study as assessed by the local MRI safety questionnaire, e.g., pacemaker\n* Vaccination or infection with fever in preceding month\n* Any stroke cause other than SVD including:\n* Cardioembolic source\n* Carotid or vertebral stenosis \\> 50% measured on NASCET (North American Symptomatic Carotid Endarterectomy Trial) criteria\n* Myocardial infarction in past year\n* Auto-immune\u002Fauto-inflammatory disease\n* Use of immunomodulating drugs\n* Estimated glomerular filtration rate (eGFR) =\\\u003C59 ml\u002Fmin\u002F1.73m2 within past 3 months for Cambridge, and eGFR =\\\u003C29 ml\u002Fmin\u002F1.73m2 within past 3 months for Nijmegen, in line with local guidelines. Estimated GFR will be calculated using the Modification of Diet in Renal Disease (MDRD) equation: 186 x (Creatinine \u002F 88.4)-1.154 x (Age)- 0.203 x (0.742 if female) x (1.210 if black). Creatinine will be checked within 3 months of the MRI, and if this has not been done as part of clinical care it will be performed as a research procedure.\n* Another diagnosed chronic neurological condition (e.g. Alzheimer's, Parkinson's disease, motor neurone disease, multiple sclerosis).\n* Limited life expectancy due to another illness or chronic condition making the 2-year follow-up difficult (e.g. widespread malignancy).\n* Known monogenic cause of small vessel disease (e.g. CADASIL - Cerebral Autosomal Dominant Arteriopathy with Sub-cortical Infarcts and Leukoencephalopathy)",{"count":587,"type":22},200,"A prospective observational cohort study in patients with cerebral small vessel disease deterring whether changes in systemic inflammation predict brain white matter damage measured using MRI and cognitive decline. This is a study funded by a joint BHF-Dutch Heart Foundation research grant and will be conducted in both Cambridge UK and Nijmegen Netherlands with 100 of the 200 total participants recruited at each site, and data from both sites analysed together.",[27,590,94],"Inflammation",[194,590,94,592,593,594,595,596],"Cerebrovascular disease","Lacunar stroke","White matter disease","Cognitive impairment","Blood brain barrier","2023-02-17",{"date":599,"type":42},"2023-02-27",{"date":601,"type":42},"2022-08-10",{"date":603,"type":22},"2026-07-31",{"name":605,"class":49},"University of Cambridge",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":82,"sex":17,"minAge":344,"maxAge":4,"enrollmentInfo":614,"targetDuration":615,"studyType":23,"phases":4,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":50},"100327409","cognitive-impairment-retinopathy-and-cerebrovascular-lesions-in-the-elderly-100327409","NCT03542734","Cognitive Impairment, Retinopathy, and Cerebrovascular Lesions in the Elderly","The Associations of Retinal Microvascular Signs and Brain Imaging Markers With Cognitive Impairment in Patients With Small Vessel Disease","CIRCLE","Inclusion Criteria:\n\n* Adult (≥40y; no upper limit)\n* Free of known dementia or stroke (both cerebral infarction and hemorrhage)\n\nExclusion Criteria:\n\n* Any MRI contraindications\n* Serious head injury (resulting to loss of consciousness) or received intracranial surgery\n* Suffering from cancer",{"count":21,"type":22},"5 Years","The CIRCLE study is a single-center prospective observational study that enrolled individuals with cerebral small vessel disease (SVD), while free of known dementia or stroke (both cerebral infarction and hemorrhage). The patients will receive neuropsychological testing, retinal digital images and multimodal magnetic resonance imaging (MRI). Blood samples will also be collected. Recent small subcortical infarcts, lacunes, white matter hyperintensities, perivascular spaces, microbleeds, and brain atrophy will be evaluated on both baseline and follow-up brain MRIs. The investigators will explore the predictors of preogression of SVD and cognitive deficits.",[27,618,374],"Retinopathy","2023-02-02",{"date":621,"type":42},"2023-02-06",{"date":623,"type":42},"2010-01-01",{"date":625,"type":22},"2031-06-30",{"name":627,"class":49},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":629,"slug":630,"hasResults":12,"nctId":631,"briefTitle":632,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":17,"minAge":443,"maxAge":136,"enrollmentInfo":636,"targetDuration":4,"studyType":139,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":645,"lastUpdatePostDateStruct":646,"startDateStruct":648,"completionDateStruct":650,"leadSponsor":651,"locationsCount":50},"100452247","phase-4-folic-acid-and-intensive-antihypertensive-therapy-for-hypertension-with-csvd-100452247","NCT05169021","Folic Acid and Intensive Antihypertensive Therapy for Hypertension With CSVD","Folic Acid and Intensive Antihypertensive Therapy for Cerebrovascular and Cardiovascular Events Prevention Among Patients With Hypertension and Cerebral Small Vascular Diseases (FAITH)----A Multicenter, Randomized, Controlled, Open-label, 2x2 Factorial, Blinded End-point Trial","FAITH","Inclusion Criteria:\n\n1. Age 35-75 years;\n2. Meets any of the following criteria:\n\n1\\) Lacunar infarction occurring within the period of seven days up to one year post-infarction, diagnosed by head MRI\u002FCT (meeting modified Fisher criteria\\*); 2）Head MRI indicating white matter hyperintensity, 4≥Fazekas score\\*≥2; 3）Head MRI indicating white matter hyperintensity, Fazekas=1, combined with old subcortical vascular lacunar infarction;\n\n* For modified Fisher criteria and Fazekas score, see FAITH main study appendix 1 and appendix 6).\n\n  3\\. Medical recorded history of hypertension. Systolic blood pressure SBP: 130-180 mm Hg on 0 or 1 medication SBP: 130-170 mm Hg on up to 2 medications SBP: 130-160 mm Hg on up to 3 medications. 4. mRS score ≤2; 5. Serum Hcy ≥10 µmol\u002FL or MTHFR 677 TT genotype; 6. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Patients with secondary hypertension;\n2. Symptomatic intracranial and extracranial artery stenosis (stenosis ≥50%), or asymptomatic intracranial and extracranial artery stenosis (stenosis≥70%);\n3. Patients who have undergone revascularization of the heart, brain, or kidney, or other aortic stenting procedures;\n4. Any symptoms of orthostatic hypotension when measuring standing blood pressure, or if standing SBP \\\u003C110mmHg;\n5. Bilateral renal artery stenosis;\n6. Patients who have previously taken candesartan or other angiotensin receptor antagonist (ARB) type medication, indapamide or other similar diuretic type medication, or any medication or health product containing folic acid, and reported adverse reactions;\n7. Patients who have indicators for specific antihypertensive medications (e.g. β-blockers after acute myocardial infarction, RAS blockers for prevention of cardiovascular disease, α-blockers for treatment of benign prostate hyperplasia);\n8. Within the last three months, regular usage of vitamin supplements containing folic acid, B6, or B12, or usage of folic acid antagonists (e.g. methotrexate);\n9. Patients undergoing dialysis or with stage 4-5 chronic kidney disease, or estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m²;\n10. History of epilepsy or currently using anti-epileptic medication;\n11. Pregnant and lactating women, or women planning to become pregnant;\n12. Life expectancy less than four years;\n13. Within the last month, participation in another clinical trial;\n14. Any patient determined by the researchers to be unsuitable for the present study.",{"count":637,"type":22},15000,[547],"The primary objectives of this trial are:\n\n1. Efficacy evaluation of amlodipine folic acid tablets:\n\n   To assess the effects of amlodipine folic acid tablets 5.8 mg (5 mg amlodipine + 0.8 mg folic acid)versus amlodipine tablets 5 mg in preventing all-cause stroke in cerebral small vascular disease (CSVD) patients with hypertension and elevated homocysteine (Hcy) level.\n2. Intensive Antihypertensive Therapy:\n\nTo assess the effect of intensive antihypertensive therapy (SBP\\\u003C130 mmHg) versus standard antihypertensive therapy (SBP 130-\\\u003C140 mmHg) in reducing risk of combined cardio-cerebrovascular events in CSVD patients with hypertension and elevated Hcy level, using two basic anti-hypertensive drugs, amlodipine tablets 5 mg or amlodipine folic acid tablets 5.8 mg.",[27,94],[27,642,144,643,644],"Stroke recurrence","Homocysteine","Folic acid","2021-12-10",{"date":647,"type":42},"2021-12-23",{"date":649,"type":22},"2021-12-31",{"date":101,"type":22},{"name":177,"class":49}]