[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-artery-plaque\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-artery-plaque":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,74,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100615773","oral-microbiome-in-carotid-atherosclerosis-100615773",false,"NCT07296965","Oral Microbiome in Carotid Atherosclerosis","The Role of the Oral Microbiome in Carotid Atherosclerosis: Investigating in a Cross-sectional Study the Microbial Influence on Plaque Development and Vulnerability Based on Biobank Data","OMICA","Inclusion Criteria:\n\n* Confirmed internal carotid artery (ICA) stenosis on preoperative photon-counting computed tomography (CTA)\n* Adults (≥18 years) undergoing carotid endarterectomy at Semmelweis University.\n* Eligible for surgery based on standard anesthesiologic evaluation.\n* Willing and able to provide written informed consent for participation and sample collection.\n\nExclusion Criteria:\n\n* Active systemic infection or current antibiotic therapy within 30 days before surgery.\n* Immunosuppressive therapy or immunodeficiency disorders.\n* Inability to undergo MRI (e.g., pacemaker, metallic implants, severe claustrophobia).\n* Pregnancy or lactation.\n* Malignancy under active treatment.\n* Prior carotid surgery or stenting on the same side.\n* Refusal or inability to provide informed consent.","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","1 Year","OBSERVATIONAL","The goal of this observational study, called OMICA (Oral Microbiome in Carotid Atherosclerosis), is to learn how bacteria living in the mouth may influence the development and stability of plaques in the carotid arteries, which supply blood to the brain. Plaque buildup in these arteries can lead to stroke.\n\nResearchers want to understand whether certain oral bacteria are linked to plaque vulnerability, meaning a higher chance that the plaque will rupture and cause a stroke.\n\nThe study will include a cohort of adults scheduled for carotid endarterectomy at Semmelweis University. Participants will be enrolled in the Semmelweis University Carotid Biobank project.\n\nThe main questions the study aims to answer are:\n\nDo people with more severe gum disease or tooth infection have a higher number of bacteria in their carotid plaques, and are those plaques more likely to rupture?\n\nAre the bacteria found in vulnerable plaques different from those in stable plaques?\n\nAre similar bacteria found in the mouth, gut, and plaques, suggesting that bacteria may travel through the body?\n\nWhat participants will do:\n\nHave their oral health checked before surgery, including an exam of gum disease and tooth infections.\n\nProvide microbiome samples from the mouth, anus, urine, and carotid plaque (taken during surgery).\n\nHave preoperative photon-counting computed tomography (CT) performed to assess plaque stability and study eligibility.\n\nAll samples and imaging data will be analyzed to identify bacterial species and their relationship to plaque type.\n\nThe study does not involve any experimental treatment or medication. Participation adds no significant medical risk beyond standard care.\n\nResearchers will compare bacterial patterns between people with vulnerable plaques and those with stable plaques to identify microbial signatures linked to carotid plaque instability.\n\nThe results may help create future microbiome-based risk models for detecting people at higher risk of stroke or severe atherosclerosis.",[26,27,28,29,30],"Atherosclerosis Cardiovascular Disease","Atherosclerosis of Artery","Carotid Artery Plaque","Periodontitis","Carotid Artery Diseases",[32,33,34,35,36,37,38],"Oral Microbiome","Carotid Plaque","Plaque vulnerability","Atherosclerosis","Periodontal disease","Biobank study","Microbial colonization","RECRUITING","2026-04-21",{"date":42,"type":43},"2026-04-22","ACTUAL",{"date":45,"type":43},"2025-11-01",{"date":47,"type":21},"2029-11-01",{"name":49,"class":50},"Semmelweis University Heart and Vascular Center","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":51},"100593302","18f-fdg-and-68ga-fapi-petmr-imaging-of-carotid-artery-plaque-vulnerability-a-clinical-study-in-carotid-artery-plaque-patients-100593302","NCT07004673","18F FDG and 68Ga FAPI PET\u002FMR Imaging of Carotid Artery Plaque Vulnerability: A Clinical Study in Carotid Artery Plaque Patients","Inclusion Criteria:\n\n-Age between 18 and 80 years; Presence of carotid atherosclerotic plaque confirmed by ultrasound within the past two weeks, with carotid intima-media thickness (IMT) ≥ 2 mm (IMT ≥ 1.2 mm is defined as carotid atherosclerosis) or carotid artery stenosis ≥ 50% as indicated by CTA.\n\nExclusion Criteria:\n\n* Absolute or relative contraindications related to PET\u002FMR imaging safety (e.g., metallic implants, MRI phobia, etc.); Patients who have undergone carotid endarterectomy (CEA) or carotid artery stenting (CAS); Pregnant or lactating women; Presence of other vascular diseases, such as vasculitis, moyamoya disease, arterial dissection, etc.; Severe agitation or inability to cooperate with imaging procedures.",true,{"count":60,"type":21},100,"Carotid atherosclerotic plaque rupture is the main cause of ischemic stroke attacks, and early and precise assessment of plaque vulnerability can prevent ischemic stroke. High-resolution MRI can reflect vulnerable plaque features such as thin fibrous caps and large lipid cores, but cannot assess their metabolic information; Fibro-activated proteins (FAPs) of PET are specifically expressed in atherosclerosis and suggest vulnerable plaques by reflecting inflammation-induced fibrosis. The aim of this study was to apply 18F FDG\\&68Ga-FAPI PET\u002FMR imaging to investigate the vulnerability of carotid atherosclerotic plaques, to obtain quantitative evaluation indexes of active fibrosis within carotid plaques, and to clarify the PET\u002FMR characteristics of unstable plaques in carotid arteries",[28,63,64],"Ischemic Stroke","PET \u002F MR","2026-03-03",{"date":67,"type":43},"2026-03-05",{"date":69,"type":43},"2025-04-12",{"date":71,"type":21},"2026-12-31",{"name":73,"class":50},"Ruijin Hospital",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":51},"100600976","phase-2-18falf-nota-octreotide-petmri-in-carotid-artery-disease-100600976","NCT07104487","[18F]AlF-NOTA-octreotide PET\u002FMRI in Carotid Artery Disease","An Exploratory Study of [18F]AlF-NOTA-octreotide PET\u002FMRI in Carotid Artery Disease","Inclusion Criteria:\n\n1. Participant is aged over 18 years.\n2. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedure\n3. CT angiography imaging at baseline should be available as part of routine care\n4. Participant is diagnosed with a recent ischemic stroke or high-risk TIA (ABCD2 ≥ 4) in the carotid artery territory and ≥ 30% carotid artery stenosis. The stroke\u002FTIA has occurred no more than 21 days prior to tracer administration.\n\nExclusion Criteria:\n\n1. Female who is pregnant or breast-feeding\n2. Participants with a cardio-embolic stroke, small vessel stroke or other defined stroke etiology according to the TOAST classification (23)\n3. Participant has a previous or ongoing recurrent or chronic disease at high risk to interfere with the performance or evaluation of the trial, according to the judgment of the investigator\n4. Participants treated with carotid endarterectomy or carotid artery stenting within the past year\n5. Subject has a contra-indication for or cannot tolerate MR scanning\n6. Subject has an impaired renal function estimated glomerular filtration rate (eGFR) \\\u003C 40 ml\u002Fmin\u002F1.73m² (the last known value may not date from more than 3 months prior to the study PET\u002FMR; if not available a blood analysis may be performed as part of the trial)\n7. Concurrent treatment with corticosteroids and\u002For somatostatin analogues\n8. Subject is unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator",{"count":82,"type":21},24,"INTERVENTIONAL",[85],"PHASE2","This clinical trial aims to evaluate whether \\[¹⁸F\\]AlF-OC PET\u002FMRI can characterize and quantify inflammation in carotid atherosclerotic plaques. The study will assess if tracer uptake in culprit and non-culprit carotid arteries, measured by standardized uptake values (SUV), is associated with future cerebrovascular events. Specifically, it will examine whether \\[¹⁸F\\]AlF-OC uptake predicts the risk of recurrent ipsilateral TIA, amaurosis fugax, stroke, or other vascular complications.\n\nParticipants will undergo \\[¹⁸F\\]AlF-OC PET\u002FMRI and will be followed via telephone interviews at 90 days, 1 year, and 3 years after their initial stroke or TIA.",[88,28,26,89],"Stroke (CVA) or TIA","Carotid Arteriosclerosis",[91,92,35,93,94,95,96,97],"Internal Carotid Artery","Molecular Imaging","Inflammation","PET\u002FMRI","SST2","[18F]AlF-NOTA-octreotide","Stroke\u002FTIA","2025-08-05",{"date":100,"type":43},"2025-08-11",{"date":102,"type":43},"2025-03-18",{"date":104,"type":21},"2029-09",{"name":106,"class":50},"Universitaire Ziekenhuizen KU Leuven",{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":83,"phases":117,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":51},"100368168","pet-imaging-of-inflammation-and-lipid-lowering-study-100368168","NCT04073797","PET Imaging of Inflammation and Lipid Lowering Study","PIILL","Inclusion Criteria:\n\n* Male or female participants \\>18 years old\n* Able to give written, informed consent and to lie flat\n* Have primary hypercholesterolaemia (non-familial or definite or possible heterozygous familial hypercholesterolaemia (HeFH) based on clinical criteria) or mixed dyslipidaemia, and\n* History of CVD (acute coronary syndrome, coronary or other revascularisation procedures, coronary heart disease, ischaemic stroke, or peripheral arterial disease) and elevated LDL cholesterol ≥2.6 despite maximum tolerated statins with or without other lipid lowering therapies (see NICE TA 733), and\n* Lipid lowering therapy unchanged for at least 6 weeks prior to screening, and\n* Pre-existing carotid atherosclerotic plaque ≥15mm by B-mode ultrasound\n\nExclusion Criteria:\n\n* Women of childbearing potential not using adequate contraception\n* Contra-indication to MRI scanning\n* Statin-associated myositis or liver function abnormality\n* Already taking inclisiran or colchicine\n* Sensitivity and\u002For contraindication to inclisiran or colchicine. Contraindications to colchicine include severe hepatic or renal impairment, blood disorders, and patients with renal or hepatic impairment who are taking a P-gp inhibitor or a strong CYP3A4 inhibitor\n* Contrast allergy or contrast-nephropathy\n* Chronic kidney disease (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Cardiovascular event within 6 months\n* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study\n* Uncontrolled chronic inflammatory disorder\n* History of recent malignancy deemed relevant to the study by the investigator\n* Treatment with medications that result in significant drug to drug interactions with the study medications\n* Current use of systemic corticosteroids or other immunosuppressive drugs\n* Previous or planned carotid endarterectomy surgery or stenting on the index side","99 Years",{"count":116,"type":21},63,[118],"NA","While 18F-fluorodeoxyglucose (FDG) positron emission tomography (PET) imaging has been used as an early marker of drug efficacy in numerous clinical cardiovascular drug trials, as a glucose analog, its signal in the vasculature lacks inflammatory cell-specificity. Moreover, high background 18F-FDG signals from the myocardium often preclude coronary artery imaging, despite attempts to suppress myocardial tracer uptake by dietary manipulation. These limitations of 18F-FDG for measuring changes in vascular inflammation arising from drug intervention highlight important unmet needs, which might be overcome by using a somatostatin receptor subtype-2 (SST2) PET tracer.",[121,122,35,28],"Hypercholesterolemia","Hypercholesterolemia, Familial","2024-07-18",{"date":125,"type":43},"2024-07-19",{"date":127,"type":43},"2023-03-20",{"date":129,"type":21},"2026-03-01",{"name":131,"class":50},"University of Cambridge"]