[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atherosclerosis-cardiovascular-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atherosclerosis-cardiovascular-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,50,77,107,135,160,192,226,253,279,314,338,368,402,431,457],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100644186","isometric-resistance-exercise-on-accelerated-atherosclerosis-in-hypertension-100644186",false,"NCT07665034","Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension","The Impact of Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension: A Study of Randomized Controlled Trial","IRE-HT","Inclusion Criteria:\n\n1. asymptomatic clinically stable adults\n2. aged 18-75 years\n3. Both genders\n4. Suboptimal BP (on stable medication) with SBP 135-160mmHG on ambulatory BP monitoring (AMBP)\n5. Agreeable to no drug changes in coming 1 year 24 weeks\n6. Agreeable to provide informed written consent form\n7. Agreeable to have AMBP and ultrasonic (FMD \\& IMT) scan third (baseline, 24 weeks and preferably 1 year)\n\nExclusion Criteria:\n\n1. relative contraindications to AMBP (e.g. atrial fibrillation)\n2. severe osteoarthritis of knee\n3. known secondary HT\n4. pregnancy\u002Fbreastfeeding\n5. active malignancy\n6. Serious coronary profiles, (unstable angina), renal or hepatic derangement\n7. Need to change medications for control BP at 24 weeks ( SBP\\>160 mmHg)",true,"ALL","18 Years","75 Years",{"count":22,"type":23},200,"ESTIMATED","INTERVENTIONAL",[26],"NA","Background:\n\nHypertension (HT) is the most common condition worldwide, predisposing to atherosclerotic disease. However, most HT patients have suboptimal BP control despite anti-HT medications. Isometric resistance exercise (IRE) (e.g. wall squat) may improve BP control, characterized by sustained muscle contraction with minimal change in muscle length and joint angle. Most randomized trials of IRE are short duration and their long-term effects on BP and atherosclerotic complications, particularly in the Chinese, remain unknown.\n\nStudy objectives:\n\n(i) To evaluate the impact of IRE on Clinic and Ambulatory BP (AMBP) in Hong Kong Chinese.\n\n(ii) To evaluate the impact of IRE on atherogeneisis surrogates (brachial flow-mediated dilation, FMD and carotid intima-media thickness IMT).\n\n(iii) To evaluate the impact of IRE on mechanisms of BP reduction, including endothelial function FMD, carotid IMT, inflammatory parameters and arterial wall stiffness (cfPWV).\n\nSetting:\n\nRandomized samples of 200 HT patients, aged 18-75 years with systolic BP 135-160mHg while on no or stable anti-HT medications.\n\nDesign: Randomized controlled IRE trial - stratified randomization with randomization block size of 4.\n\n1. 100 patients for wall squat exercise of 14 mins each session (2 mins IRE x 4 sets, 2 mins rest in between), 3 sessions per week, for 1 year, plus advice on healthy diet and lifestyle.\n2. 100 control patients (usual care) with advice on diet and healthy lifestyles and simple stretching exercise programme (yoga) for 1 year.\n\nAll patients will be invited to continue their exercise programme and return for follow up FMD and carotid IMT at 24 weeks and 1 year, and PWV at 24 weeks.\n\nMain outcome measures:\n\n1. BP - Clinic BP and Ambulatory BP parameters at baseline, 12 weeks and 24 weeks. (primary outcome)\n2. Brachial FMD and carotid IMT at baseline, 24 weeks and 1 year. (primary outcome)\n3. Carotid-femoral pulse wave velocity (cf-PWV) at baseline and 24 weeks.\n4. Important atherosclerosis risk factor parameters at baseline, 24 weeks and 1 year - including fasting serum glucose, lipid profiles, HgbA1-C, creatinine, hs-CRP, CBP, fibrinogen, and interleukin 6 (IL-6).\n5. Safety profiles (if any) including CVS event and hospitalization at 1 year.\n\nExpected results: IRE Intervention versus control group, (i) 3mHg more reduction in SBP (Clinic and AMBP). (ii) A group absolute difference in FMD of 1%, and in carotid IMT of 0.06mm between the 2 treatment groups.\n\nImplications: IRE as suggested will be beneficial to management of HT, and will be of great importance in health care of this common disorder in both primary and secondary preventions of atherosclerosis diseases.",[29],"Atherosclerosis Cardiovascular Disease",[31,32,33,34,35,36],"Isometric Resistance Exercise","Essential Hypertension","Atherosclerosis","Brachial FMD","Carotid IMT","Atherosclerosis Prevention","RECRUITING","2026-06-23",{"date":40,"type":41},"2026-06-24","ACTUAL",{"date":43,"type":41},"2025-10-15",{"date":45,"type":23},"2027-07-30",{"name":47,"class":48},"Chinese University of Hong Kong","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":17,"sex":18,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":24,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100613171","evaluation-of-the-association-between-the-effects-of-generalized-stage-3-and-4-periodontitis-on-arterial-stiffness-and-cardiovascular-risk-the-parocar-study-100613171","NCT07263113","Evaluation of the Association Between the Effects of Generalized Stage 3 and 4 Periodontitis on Arterial Stiffness and Cardiovascular Risk: the PAROCAR Study","PAROCAR","Inclusion Criteria:\n\n* Age 40-69 years\n* Minimum of 12 teeth (3 per quadrant)\n* Written informed consent Exposed group: generalized periodontitis stage 3 or 4 (Chicago 2017 Classification) Non-exposed group: healthy periodontium\n\nExclusion Criteria:\n\n* Patients diagnosed with diabetes,\n* Patients diagnosed with hypertension or with a history of severe cardiovascular disease,\n* Patients diagnosed with familial hypercholesterolaemia,\n* Patients with a medical history or current condition that, in the investigator's opinion, is likely to interfere with the study results,\n* Patients with a BMI ≥ 30 kg\u002Fm²,\n* Patients who have previously undergone periodontal treatment,\n* Patients who consume more than 2 units of alcohol per day,\n* Patients who refuse to participate in the study,\n* Minors and patients under the age of 40,\n* Adult patients under legal protection (guardianship, curatorship),\n* Patients deprived of their liberty,\n* Pregnant or breastfeeding women,\n* Patients not affiliated with a health insurance scheme (AME)\n* Patients already included in another interventional study","40 Years","69 Years",{"count":60,"type":23},206,[26],"Periodontal diseases are chronic inflammatory conditions affecting nearly half of the adult population and are associated with systemic inflammatory responses. Recent evidence suggests a possible link between severe periodontitis and cardiovascular diseases through shared inflammatory pathways.\n\nThe PAROCAR study aims to evaluate the association between generalized periodontitis (stages 3 and 4, 2017 Chicago Classification) and arterial stiffness measured by pulse wave velocity (PWV), compared to matched controls without periodontitis, adjusted for conventional cardiovascular risk factors.",[64,29],"Periodontis",[66,33,67,68],"periodontis","Cardiovascular Risk","Arterial Stiffness","2026-06-22",{"date":38,"type":41},{"date":72,"type":41},"2026-04-10",{"date":74,"type":23},"2027-12-01",{"name":76,"class":48},"Nantes University Hospital",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":24,"phases":87,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":106},"100611500","phase-3-a-study-of-orforglipron-ly3502970-on-cardiovascular-outcomes-in-adults-with-atherosclerotic-cardiovascular-disease-andor-chronic-kidney-disease-attain-outcomes-100611500","NCT07241390","A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease (ATTAIN-Outcomes)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Orforglipron on the Incidence of Major Adverse Cardiovascular Events in Participants With Established Atherosclerotic Cardiovascular Disease and\u002For Chronic Kidney Disease","Inclusion Criteria:\n\n* Have established ASCVD and\u002For CKD\n\nExclusion Criteria:\n\n* Have type 1 diabetes\n* Have had a major heart condition within 60 days prior to screening\n* Have New York Heart Association Functional Classification Class IV heart failure","50 Years",{"count":86,"type":23},7140,[88],"PHASE3","The purpose of this study is to measure cardiovascular outcomes with orforglipron compared with placebo in participants with atherosclerotic cardiovascular disease (ASCVD) and\u002For chronic kidney disease (CKD). Participation in the study will last about 5 years.",[29,91],"Chronic Kidney Disease",[93,94,95,96],"Heart Disease","Kidney Disease","Outcomes","Stroke","2026-06-19",{"date":38,"type":41},{"date":100,"type":41},"2025-12-01",{"date":102,"type":23},"2031-08",{"name":104,"class":105},"Eli Lilly and Company","INDUSTRY",568,{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":114,"targetDuration":116,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":4},"100642567","effects-of-icosapent-ethyl-on-coronary-plaque-inflammation-and-ventricular-remodeling-100642567","NCT07641257","Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular Remodeling","Impact of Icosapent Ethyl on Ventricular Remodeling, Inflammation, and Coronary Plaque Stability in Patients With Acute or Chronic Coronary Syndrome: A Prospective, Observational, Real-World Study","Inclusion Criteria:\n\n* Age 18 years and older, of any sex.\n\n  * Definite diagnosis of chronic coronary syndrome (CCS) according to the Chinese Guidelines for the Diagnosis and Management of Patients with Chronic Coronary Syndrome, or acute coronary syndrome (ACS) according to the 2025 ACC\u002FAHA\u002FACEP\u002FNAEMSP\u002FSACI Guideline for the Management of Acute Coronary Syndromes.\n  * Laboratory evaluation showing fasting triglycerides (TG) \\>= 1.7 mmol\u002FL.\n  * Ability to fully understand the study purpose, voluntary participation, and provision of signed written informed consent.\n\nExclusion Criteria:\n\n* Women who are planning a pregnancy, currently pregnant, or lactating.\n\n  * Known hypersensitivity or allergic reaction to the active ingredient of icosapent ethyl (IPE) or any of its excipients (applicable to patients in the exposure cohort).\n  * Diagnosed with major life-threatening conditions such as malignant tumors, end-stage lung disease, or advanced neurodegenerative diseases, with a life expectancy of less than 12 months.\n  * Concurrent participation in any other interventional clinical trial involving investigational drugs or medical devices.\n  * Any other condition or severe non-compliance that, in the judgment of the investigator, makes the patient unsuitable for enrollment in this study.",{"count":115,"type":23},420,"12 Months","OBSERVATIONAL","Even with standard treatments like statins, patients with coronary artery disease often face a residual risk of further heart events. This risk is largely driven by ongoing inflammation and unstable fatty plaques in the heart's blood vessels. Icosapent ethyl (IPE) is a highly purified prescription medication known to improve cardiovascular outcomes, but its detailed effects on the heart's structure and inflammation in everyday clinical practice need further exploration.\n\nThis study is a prospective, observational, real-world study designed to evaluate the effectiveness of IPE in patients with Acute Coronary Syndrome (ACS) or Chronic Coronary Syndrome (CCS). The study plans to enroll 420 patients who will be followed for 12 months. Based on their routine clinical prescriptions, participants will be grouped into a control group (receiving standard cardiovascular care, including statins) and an exposure group (receiving standard care plus IPE).\n\nThroughout the 1-year follow-up, researchers will conduct regular blood tests and advanced heart imaging. The main goal is to determine if adding IPE to standard therapy leads to a more significant reduction in inflammation. Additionally, the study will observe how IPE affects the stability of coronary plaques and the healing process of ventricular remodeling in a real-world clinical setting.",[120,121,122,29,123,124],"Acute Coronary Syndromes (ACS)","Chronic Coronary Syndrome","Coronary Artery Disease","Ventricular Remodeling","Inflammation","NOT_YET_RECRUITING","2026-06-08",{"date":128,"type":41},"2026-06-11",{"date":130,"type":23},"2026-05-30",{"date":132,"type":23},"2029-05-30",{"name":134,"class":48},"Ruijin Hospital",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":142,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":155,"leadSponsor":157,"locationsCount":159},"100616297","phase-2-efficacy-safety-and-poppk-profile-of-abp-745-in-patients-with-atherosclerosis-100616297","NCT07303777","Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis","Inclusion Criteria:\n\nUnless otherwise specified, subjects must meet all of the following criteria at screening:\n\n* Diagnosed with coronary at herosclerosis, and coronary angiography.\n* Male or female at 18-75 years of age (inclusive).\n* Weight ≥40 kg.\n* Currently using any oral lipid-lowering therapy.\n* Able to understand and willing to sign an ICF and comply with study requirements.\n* A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.\n\nExclusion Criteria:\n\nUnless otherwise specified, subjects are excluded from the study if any of the following criteria is met:\n\n* History of stroke within the past 6 months.\n* Uncontrolled arrhythmia within 3 months prior to screening.\n* Evidence of any active or suspected cancer within 3 years prior to the screening.\n* Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.\n* Presence or suspicion of ongoing of any serious infection.\n* Human immunodeficiency virus (HIV) infection.",{"count":22,"type":23},[144],"PHASE2","This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.",[29,147,148],"ASCVD","ASCVD Management",[147,150],"ABP-745","2026-04-23",{"date":153,"type":41},"2026-04-28",{"date":151,"type":41},{"date":156,"type":23},"2028-04",{"name":158,"class":105},"Atom Therapeutics Co., Ltd",33,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":168,"targetDuration":169,"studyType":117,"phases":4,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":49},"100615773","oral-microbiome-in-carotid-atherosclerosis-100615773","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.",{"count":22,"type":23},"1 Year","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.",[29,172,173,174,175],"Atherosclerosis of Artery","Carotid Artery Plaque","Periodontitis","Carotid Artery Diseases",[177,178,179,33,180,181,182],"Oral Microbiome","Carotid Plaque","Plaque vulnerability","Periodontal disease","Biobank study","Microbial colonization","2026-04-21",{"date":185,"type":41},"2026-04-22",{"date":187,"type":41},"2025-11-01",{"date":189,"type":23},"2029-11-01",{"name":191,"class":48},"Semmelweis University Heart and Vascular Center",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":17,"sex":18,"minAge":199,"maxAge":200,"enrollmentInfo":201,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":203,"conditions":204,"keywords":208,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":49},"100629404","associations-between-dietary-patterns-ldl-aggregation-and-cardiometabolic-health-a-cross-sectional-analysis-100629404","NCT07474233","Associations Between Dietary Patterns, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.","Associations Between Dietary Pattern Adherence, LDL Aggregation, and Cardiometabolic Health: A Cross-sectional Analysis.","Inclusion Criteria:\n\n* Adults aged 25-60 years.\n* BMI range (18.5-29.9 kg\u002Fm²).\n* Following one of the specified dietary patterns (vegan\u002Fplant-based, carnivore, or omnivorous) for a minimum of 6 months.\n* Self-identified as health-focused (i.e., intentionally following the diet for perceived health benefits).\n\nExclusion Criteria:\n\n* BMI outside the stated range (\\\u003C18.5 or ≥30 kg\u002Fm²).\n* Use of lipid-lowering medications or supplements that may interfere with LDL levels.\n* Pregnancy or breastfeeding.\n* Any significant deviation from the specified diet within the last month.","25 Years","60 Years",{"count":202,"type":23},90,"This study aims to investigate the extent to which vegan or plant-based, omnivorous, and carnivore dietary patterns affect LDL aggregation susceptibility (the affinity for LDL cholesterol particles to clump together in the blood), which may promote plaque build-up in arteries. Using a cross-sectional mixed-methods design, the study will measure LDL aggregation, blood lipids, and other metabolic biomarkers in individuals following these diets, and combine these data with dietary and behavioural information to examine links with cardiovascular and metabolic health.",[29,205,206,207],"Metabolic Syndrome","Dyslipidaemia","Endothelial Dysfunction",[209,210,33,211,212,213,214,215,216],"LDL aggregation","Dietary patterns","Cardiovascular disease","Onmivore diet","Vegan diet","Carnivore diet","Lipid profile","Cardiometabolic health","2026-03-11",{"date":219,"type":41},"2026-03-16",{"date":221,"type":23},"2026-05",{"date":223,"type":23},"2027-05",{"name":225,"class":48},"Liverpool John Moores University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":17,"sex":18,"minAge":234,"maxAge":200,"enrollmentInfo":235,"targetDuration":4,"studyType":24,"phases":237,"briefSummary":238,"conditions":239,"keywords":240,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":49},"100628533","comparative-effects-of-carnivore-and-mediterranean-style-diets-on-ldl-aggregation-and-cardiometabolic-health-100628533","NCT07462871","Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation and Cardiometabolic Health","Comparative Effects of Carnivore and Mediterranean-style Diets on LDL Aggregation Susceptibility and Cardiometabolic Health","MEDIVORE","Inclusion Criteria:\n\n* Male or female\n* 30-60 years of age\n* Elevated LDL cholesterol (LDL \\>3mmol\u002FL and\u002For non-HDL cholesterol \\> 4mmol\u002FL)\n* Not following any specific diet for health reasons.\n* Not currently taking lipid-lowering medications or supplements that may interfere with LDL levels.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Known food allergies or intolerances.\n* Previous history of disordered eating.\n* Currently taking cholesterol-lowering medication or supplements.","30 Years",{"count":236,"type":23},30,[26],"The goal of this clinical trial is to learn whether following a Mediterranean-style diet or a Carnivore-style diet can improve heart and metabolic health in men and women aged 30-60 years with high LDL cholesterol.\n\nThe main questions it aims to answer are:\n\n1. Does following a Mediterranean or Carnivore diet change how easily LDL cholesterol particles clump together (LDL aggregation susceptibility)?\n2. Do these two diets have different effects on other measures of heart and metabolic health, such as blood fats, blood vessel function, and overall wellbeing?\n\nResearchers will compare people who follow the Mediterranean-style diet with those who follow the Carnivore-style diet to see which diet produces more beneficial changes in cholesterol and heart health markers.\n\nParticipants will:\n\n* Attend three visits at Liverpool John Moores University for screening and data collection.\n* Be randomly assigned to follow either the Mediterranean or Carnivore diet for 3 weeks, matched for calories and protein.\n* Provide fasting blood, urine, and stool samples before and after the diet period.\n* Complete non-invasive cardiovascular tests to measure blood vessel and heart function.\n* Take part in a short interview and complete questionnaires about their experience of following the diet.",[29,205,206],[33,147,241,242,209,243,244,245],"Diet, carbohydrate-restricted","Ketogenic diet","Low-density lipoproteins","Lipoproteins","Lipid metabolism",{"date":247,"type":41},"2026-03-13",{"date":249,"type":23},"2026-06",{"date":251,"type":23},"2027-06",{"name":225,"class":48},{"id":254,"slug":255,"hasResults":11,"nctId":256,"briefTitle":257,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":57,"enrollmentInfo":259,"targetDuration":4,"studyType":24,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":49},"100625393","phase-2-erythrodiol-in-pomace-olive-oil-as-a-protective-agent-against-atherosclerosis-100625393","NCT07422051","Erythrodiol in Pomace Olive Oil as a Protective Agent Against Atherosclerosis","Inclusion Criteria:\n\n* Adults aged 18 to 40 years.\n* Male or female volunteers.\n* Healthy individuals with no diagnosed diseases.\n* Normal-weight participants with a Body Mass Index (BMI) between 18.5 and 24.9 kg\u002Fm².\n* Ability to provide voluntary informed consent.\n* Willingness to comply with all study procedures.\n* Availability to participate in the two-phase selection process, including initial screening and subsequent laboratory tests.\n\nExclusion Criteria:\n\n* Presence of any type of disease, including digestive, metabolic, endocrine, infectious, neoplastic conditions, or associated allergies and food intolerances.\n* Current use of any medication, except hormonal contraceptives.\n* Pregnant or breastfeeding women.\n* Participation in a clinical trial with an investigational product within the last 60 days, or current enrolment in a clinical trial.\n* Any physical or intellectual limitation that, in the opinion of the investigator, could impede following or completing the study protocol.",{"count":260,"type":23},22,[144],"The goal of this postprandial clinical trial is to learn whether erythrodiol, a triterpene naturally present in pomace olive oil, can modulate the cell foam formation, ine of the first steps in atherosclerosis. The main questions it aims to answer are:\n\nIs erythrodiol bioavailable in humans when administered as pomace olive oil? Does acute erythrodiol intake reduce postprandial triglyceride excursions after a high-fat meal? Does erythrodiol reduce the intake of postprandial triglyceride-rich lipoproteins by macrophages?\n\nResearchers will compare participants receiving test meals enriched with different concentrations of erythrodiol (low, medium, high) to see if the intervention leads to improved postprandial metabolic and vascular responses.\n\nParticipants will:\n\nAttend the research facility after an overnight fast. Consume a high-fat test meal enriched with a different doses of erythrodiol\n\nUndergo serial postprandial assessments over several hours, including:\n\nBlood sampling for lipids, glucose, inflammatory markers, and oxidative stress biomarkers Monitoring of subjective tolerability and adverse events",[29],[265,266,267,33,268],"Randomized postprandial crossover trial","Erythrodiol","Pomace olive oil","Macrophages","2026-02-18",{"date":271,"type":41},"2026-02-19",{"date":273,"type":23},"2026-02-21",{"date":275,"type":23},"2026-12-30",{"name":277,"class":278},"Spanish National Research Council","OTHER_GOV",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":285,"eligibilityCriteria":286,"healthyVolunteers":17,"sex":18,"minAge":287,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":24,"phases":291,"briefSummary":292,"conditions":293,"keywords":299,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":310,"leadSponsor":312,"locationsCount":49},"100620766","deciphering-the-effect-of-moderate-wine-consumption-on-healthy-aging-through-postprandial-extracellular-vesicles-100620766","NCT07361887","Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles.","Deciphering the Effect of Moderate Wine Consumption on Healthy Aging Through Postprandial Extracellular Vesicles","(WINEVOME)","Inclusion Criteria\n\n* Healthy adult men and women aged 35 to 65 years.\n* Body Mass Index (BMI) between 18.5 and 29.9 kg\u002Fm².\n* Non-smokers or ex-smokers for at least 12 months.\n* Moderate alcohol consumers, defined as ≤2 units\u002Fday for men and ≤1 unit\u002Fday for women.\n* Normal fasting glucose and lipid profile at screening.\n* Willing and able to refrain from alcohol, polyphenol-rich foods, and intense exercise for 48 hours before each study visit.\n* Able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria\n\n* History or clinical evidence of cardiovascular, hepatic, renal, thyroid, gastrointestinal, or metabolic diseases (including diabetes, dyslipidemia, or hypertension).\n* Use of medications or supplements known to affect glucose, lipid, or inflammatory metabolism (e.g., statins, corticosteroids, anti-inflammatory drugs).\n* Pregnancy or breastfeeding.\n* Recent blood donation (within the last 3 months) or planned blood donation during the study period.\n* Major weight change (\\>5% of body weight) within the last 3 months.\n* Participation in another clinical or biomedical study within the previous 3 months.\n* Known allergy or intolerance to wine, alcohol, or its components (e.g., sulfites).\n* History of alcohol abuse or inability to abstain from alcohol outside the study context.\n* Reluctance to receive information about incidental health findings arising from the study.\n* Any condition judged by the investigators to limit compliance or increase study risk (e.g., psychiatric disorders, inability to adhere to fasting requirements).","35 Years","36 Years",{"count":290,"type":23},8,[26],"This study aims to investigate how moderate wine consumption influences circulating extracellular vesicles (EVs) in healthy adults. EVs are small particles released by cells that carry proteins, lipids, and genetic material, and play important roles in communication between cells. Participants will consume a single serving of red or white wine, and blood samples will be collected before and after consumption to study changes in the composition and function of EVs. The study will also assess how these EVs affect vascular, immune, and brain-related cells. The results are expected to improve our understanding of how moderate wine intake contributes to cardiovascular and brain health.",[29,294,205,295,124,296,297,298],"Obesity","Metabolic Disorders","Neurodegeneration","Neurodegenerative Disease","Alzheimer s Disease",[300,301,302,303,304,305],"blood-brain barrier","microglia","extracellular vesicles","lipidome","proteome","vascular disease","2026-01-14",{"date":308,"type":41},"2026-01-23",{"date":187,"type":41},{"date":311,"type":23},"2027-03-31",{"name":313,"class":48},"University of Seville",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":337},"100611215","evaluating-atherosclerotic-disease-progression-in-patients-with-diabetes-mellitus-100611215","NCT07237685","Evaluating Atherosclerotic Disease Progression in Patients With Diabetes Mellitus","Evaluating Atherosclerotic Disease Progression in High-Risk Patients With Diabetes Mellitus","EVOLVE","Inclusion Criteria:\n\n* Age over 18 years\n* Previous completion of CCTA scan for CAD assessment\n* Diagnosed with Type 2 Diabetes and currently receiving glucose lowering treatment\n* Sufficient image quality of the CCTA scan (at least 2\u002F3 vessels of sufficient quality for assessment).\n\nExclusion Criteria:\n\n* Inability to provide written informed consent\n* Presence of an unstable condition\n* Ingeligibility for CCTA acquisition due to severe renal dysfunction (eGFR ≤ 30 mL\u002Fmin\u002F1.73m²) or known hypersensitivity or contraindication to CT contrast agents\n* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator\n* inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study\n* Baseline (routine care) CCTA performed \\\u003C 2 years or \\> 5 years before inclusion",{"count":323,"type":23},1000,"People with type 2 diabetes have a much higher risk of heart disease. One common problem is when the blood vessels that supply the heart become narrowed or blocked by fatty deposits, called plaque. This makes it harder for blood to reach the heart and can lead to serious problems such as chest pain, heart attacks, or even death.\n\nThis study will follow people with type 2 diabetes who have already had a special heart scan called a coronary CT angiography. This scan takes detailed pictures of the heart's blood vessels.\n\nThe goal is to understand how heart disease changes over time in people with type 2 diabetes, by looking at repeat scans and other health information. By learning more about how plaque builds up or gets worse, researchers hope to find better ways to identify which patients are most at risk for future heart problems.",[326,327,29],"Type 2 Diabetes","Coronary Artery Disease (CAD)","2025-11-18",{"date":330,"type":41},"2025-11-20",{"date":332,"type":41},"2025-06-06",{"date":334,"type":23},"2036-10-01",{"name":336,"class":48},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",2,{"id":339,"slug":340,"hasResults":11,"nctId":341,"briefTitle":342,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":345,"targetDuration":4,"studyType":24,"phases":347,"briefSummary":348,"conditions":349,"keywords":352,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":49},"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":346,"type":23},24,[144],"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.",[350,173,29,351],"Stroke (CVA) or TIA","Carotid Arteriosclerosis",[353,354,33,124,355,356,357,358],"Internal Carotid Artery","Molecular Imaging","PET\u002FMRI","SST2","[18F]AlF-NOTA-octreotide","Stroke\u002FTIA","2025-08-05",{"date":361,"type":41},"2025-08-11",{"date":363,"type":41},"2025-03-18",{"date":365,"type":23},"2029-09",{"name":367,"class":48},"Universitaire Ziekenhuizen KU Leuven",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":376,"targetDuration":4,"studyType":24,"phases":378,"briefSummary":380,"conditions":381,"keywords":386,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":401},"100562719","phase-4-the-effects-of-tirzepatide-in-people-with-overweightobesity-and-coronary-artery-disease-100562719","NCT06606821","The Effects of Tirzepatide in People With Overweight\u002FObesity and Coronary Artery Disease","The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People With Coronary Disease - The IDEAL-COR Study","IDEAL-COR","Inclusion Criteria:\n\n* Informed written consent\n* BMI equal to or above 27 kg\u002Fm2\n* Age 18 years or older\n* Referred to coronary angiogram (CAG) due to stable angina\n* Coronary atheromatosis by angiography (obstructive or non-obstructive)\n* LCBI4mm \\>200 by NIRS in a vessel not subjected to coronary intervention\n\nExclusion Criteria:\n\n* History of diabetes or HbA1c ≥48 mmol\u002Fmol (6.5%) at baseline\n* Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)\n* History of coronary artery bypass surgery (CABG)\n* Planned CV intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation\n* History of heart failure New York Heart Association (NYHA) class III or IV\n* Left ventricular ejection fraction (LVEF) ≤35%\n* eGFR \\\u003C30 ml\u002Fmin\u002F1.53 m2\n* History of pancreatitis or plasma amylase \\>2 times upper normal limit\n* Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3 times the upper limit of normal)\n* Pregnancy, planned pregnancy or breastfeeding\n* Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)\n* Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients\n* Left main stenosis (≥50% diameter or haemodynamically significant)\n* Chronic total occlusion of any major coronary vessel\n* Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery\n* Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention",{"count":377,"type":23},124,[379],"PHASE4","The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.",[122,382,383,384,385,29],"Coronary Microvascular Dysfunction","Overweight or Obesity","Stable Angina Pectoris","Chronic Coronary Artery Disease",[387,388,389,390,391,384],"NIRS","IVUS","GLP-1","Tirzepatide","Intravascular imagining","2025-05-19",{"date":394,"type":41},"2025-05-22",{"date":396,"type":41},"2024-10-01",{"date":398,"type":23},"2028-08-01",{"name":400,"class":48},"Tina Vilsbøll",3,{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":24,"phases":411,"briefSummary":412,"conditions":413,"keywords":416,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":49},"100581935","phase-4-randomized-comparison-of-morning-versus-bedtime-administration-of-statins-a-cardiovascular-circadian-chronotherapy-c3-trial-100581935","NCT06856772","Randomized Comparison of Morning Versus Bedtime Administration of Statins: A Cardiovascular Circadian Chronotherapy (C3) Trial","STATIN-C3","Inclusion Criteria:\n\n* Age \\>=18 years\n* Current treatment with atorvastatin 10-80 mg, rosuvastatin 5-40 mg, simvastatin 10-80 mg or pravastatin 20-40 mg (as recorded in the Danish National Prescription Registry and confirmed by the participant via questionnaire)\n* Signed informed consent\n\nExclusion Criteria:\n\n* none",{"count":410,"type":23},42000,[379],"Statins inhibit hydroxy-methylglutaryl coenzyme A (HMG-CoA) reductase which catalyzes the rate-limiting step in cholesterol synthesis. This in turn leads to reductions in concentrations of low-density lipoprotein (LDL) cholesterol and C-reactive protein which reduces the risk of incident atherosclerotic events among individuals both with and without a history of atherosclerotic cardiovascular Several pilot studies have suggested potential benefits of taking statin in the evening rather than in the morning.\n\nThe primary objective of this study is to examine whether statin administration at bedtime versus in the morning provides a superior reduction in the incidence of major adverse cardiovascular events among patients with or without established atherosclerotic cardiovascular disease, who are already taking statin.",[414,415,29],"Cardiovascular Diseases (CVD)","Drug Effect",[417,418,419,420,95,211,421],"Statin","Circadian Rhythm","Randomized Controlled Trial","Pragmatic","Prevention","2025-02-26",{"date":424,"type":41},"2025-03-04",{"date":426,"type":23},"2025-02-28",{"date":428,"type":23},"2028-03-28",{"name":430,"class":48},"Tor Biering-Sørensen",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":18,"minAge":438,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":24,"phases":441,"briefSummary":442,"conditions":443,"keywords":444,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":449,"startDateStruct":451,"completionDateStruct":453,"leadSponsor":455,"locationsCount":4},"100571469","effect-of-icosapent-ethyl-ester-ipe-to-reduce-the-residual-risk-cardiovascular-disease-100571469","NCT06720662","Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.","Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk in Patients Undergoing Secondary Prevention for Cardiovascular Disease.","Inclusion Criteria: individuals from both sexes, aging 45 years or older having established CVD, without contraindications to the use of IPE, receiving a stable dose of a statin (± ezetimibe) for ≥4 weeks. Women should be not pregnant, not breastfeeding, not planning on becoming pregnant, and using an acceptable form of birth control during the study (if of child-bearing potential). Biomarkers should be:\n\nhsCRP level - mg\u002Fliter: from 1 to 4.5; Triglyceride level - mg\u002Fdl: from 150 - 500; HDL cholesterol level - mg\u002Fdl: from 30 - 50 and LDL cholesterol level - mg\u002Fdl: from 40 - 100.\n\nExclusion Criteria: Patients with severe heart failure, active severe liver disease, a glycated hemoglobin level greater than 10.0%, a planned coronary intervention or surgery, a history of acute or chronic pancreatitis, or known hypersensitivity to fish, shellfish, or ingredients of icosapent ethyl or placebo. Autoimmune disease requiring the use of immunosuppressive therapy or current use of systemic corticosteroid therapy; Active neoplasm with indication for surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasia and who have undergone curative surgery without the need for treatment in the last 12 months will be allowed); Inflammatory bowel disease or chronic diarrhea; Clinically significant non-transient hematological abnormalities; Renal dysfunction (GFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For serum creatinine \\> 2.5 mg\u002FdL or \\\u003C 220 μmol\u002Fl); Severe liver disease (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\] \\> 3x ULN in the last 6 months); Inability to sign the free and informed consent form; Participation in another clinical trial involving an investigational agent within 90 days prior to screening; Intolerance or hypersensitivity to statin therapy; History of acute or chronic pancreatitis; Malabsorption syndrome and\u002For chronic diarrhea; Use of non-study drug-related, non-statin, lipid-altering medications, dietary supplements, Niacin (\\>200 mg\u002Fd) or fibrates (unless ≥28-day washout). Any n-3 fatty acid medications (unless ≥28-day washout). Bile acid sequestrants (unless ≥7-day washout), PCSK9 inhibitors (unless ≥90-day washout); Other medications (not indicated for lipid alteration): Tamoxifen, estrogens, progestins, thyroid hormone therapy, systemic corticosteroids (local, topical, inhalation, or nasal corticosteroids are allowed), HIV-protease inhibitors that have not been stable for ≥28 days prior to the qualifying lipid measurements (TG and LDL-C) during screening. Cyclophosphamide or systemic retinoids during the screening period (unless ≥28- day washout) and\u002For plans for use during the treatment\u002Ffollow-up period ; HIV-positive patients even without AIDS; Requirement for peritoneal dialysis or hemodialysis for renal insufficiency or creatinine clearance 5 × ULN or elevation due to known muscle disease; Drug or alcohol abuse within the past 6 months, and inability\u002Funwillingness to abstain from drug abuse and excessive alcohol consumption during the study; 16 Mental\u002Fpsychological impairment or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study.\n\nPatients with Atrial fibrillation and Bleeding related disorders.\n\n\\-","45 Years",{"count":440,"type":23},294,[26],"Cardiovascular diseases (CVDs) are the leading cause of global mortality, despite significant advances in prevention and treatment. Atherosclerosis, a chronic inflammatory condition, underlies ischemic events such as infarction and stroke, triggered by the instability and rupture of plaques. Current guidelines recommend drugs primarily aimed at reducing Low-Density-Lipoprotein cholesterol (LDL-C), arterial pressure, and glucose levels for atherosclerosis patients. However, there is little option of approved medications specifically targeting inflammation within the arterial plaques. Consequently, a significant proportion of patients face residual risks. On the contrary, numerous studies have highlighted the anti-inflammatory effects provided by omega-3 fatty acids (n-3 FA), specially the eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and their derived oxylipins. These molecules exhibit the ability to enhance the phenotype of macrophages, increasing their capacity for efferocytosis, thereby improving plaque stability. Icosapent ethyl (IPE) is an esterifed version of eicosapentaenoic acid (EPA) and acts as a prodrug in the body to exert its effects. Icosapent ethyl (IPE) was the first fish oil product approved by the US Food and Drug Administration (FDA) to reduce the risk of atherosclerotic cardiovascular disease (ASCVD) in adults. Hence, the hypothesis of this study is that supplementing patients with IPE, in addition to their standard clinical treatment, will enhance macrophage functionality, thereby reducing inflammatory and oxidative stress biomarkers in comparison to a placebo. To test this hypothesis,a Randomized, Double-blind, Placebo-controlled Clinical trial will be performed, in which 294 patients under secondary prevention for CVDs will receive a 6-month supplementation of purified eicosapentaenoic acid-icosapent ethyl (4.0 g) daily or a Placebo (corn oil). Blood samples and anthropometric measurements will be taken at the beginning and end of the period. Basic clinical markers will be assessed, and monocytes will be collected and characterized. Fatty acid profiles and oxylipins will be determined through chromatography coupled with mass spectrometry. Finally, changes in biomarkers for both groups will undergo multivariate analysis to identify characteristics associated with the response to supplementation. Data from this study aims to provide support for physicians considering the prescription of bioactive compounds as a complementary therapy for atherosclerosis, with the goal of reducing residual risks and subsequently decreasing mortality resulting from cardiovascular events.",[29],[445,446,447],"omega 3 fatty acids","atherosclerosis","oxylipins","2024-12-09",{"date":450,"type":41},"2024-12-13",{"date":452,"type":23},"2025-04-01",{"date":454,"type":23},"2026-01-30",{"name":456,"class":48},"University of Sao Paulo",{"id":458,"slug":459,"hasResults":11,"nctId":460,"briefTitle":461,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":463,"minAge":464,"maxAge":84,"enrollmentInfo":465,"targetDuration":4,"studyType":24,"phases":467,"briefSummary":468,"conditions":469,"keywords":470,"overallStatus":125,"whyStopped":4,"lastUpdateSubmitDate":448,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":4},"100572294","variability-in-human-fatty-acids-profiles-based-on-blood-fractions-and-metabolic-conditions-100572294","NCT06731400","Variability in Human Fatty Acids Profiles Based on Blood Fractions and Metabolic Conditions","Inclusion Criteria:\n\n* Individuals of both sexes\n* Aged between 20 and 50 years\n* No contraindications for the use of fish oil supplements\n\nExclusion Criteria:\n\n* Use of medications or supplements to reduce triacylglycerols;\n* Consumption of fish oil or other supplements\u002Fmedicines rich in n-3 or n-6 PUFA in the month before the test;\n* Consumption of fatty fish (salmon, herring, mackerel, white tuna or sardines) more than twice a month in the month before the test;\n* Refusal to avoid PUFA supplements and seafood during the study period;\n* Severe heart failure;\n* Severe active liver disease;\n* Planned coronary intervention or surgery,\n* History of acute or chronic pancreatitis;\n* Hypersensitivity to fish, shellfish or capsule ingredients;\n* Autoimmune diseases requiring immunosuppressive therapy;\n* Current corticosteroid use systemic,\n* Neoplasms;\n* Chemotherapy or radiotherapy within the past 12 months (patients who have undergone curative surgery without requiring additional treatment within the past year may be included);\n* Inflammatory bowel disease;\n* Chronic diarrhea;\n* Significant non-transient hematological abnormalities;\n* Kidney dysfunction;\n* Severe liver disease;\n* Inability to provide informed record;\n* Participation in another clinical trial with an experimental agent in the last 90 days;\n* Malabsorption syndrome;\n* Recent drug or alcohol abuse;\n* Atrial fibrillation;\n* Bleeding disorders.\n* Pregnancy\n* Breastfeeding.","FEMALE","20 Years",{"count":466,"type":23},6,[26],"Fatty acids play a crucial role in various metabolic pathways, with their proportions and distributions across different cells and tissues influenced by diet and metabolism. In addition to providing energy through oxidative reactions, fatty acids serve as substrates for the synthesis of numerous molecules involved in cellular signaling processes. Therefore, quantifying fatty acids in biological samples is essential for ensuring the quality of clinical trials involving lipids and for understanding the relationship between fats and health conditions. However, the fatty acid profiles reported in clinical trials can exhibit significant heterogeneity due to both endogenous and exogenous factors, including the metabolic condition of the patients and the specific blood fraction analyzed. This variability makes difficult the comparison of results across studies. Moreover, despite the crucial role of fatty acids in immune response, most results are derived from erythrocytes, plasma, or serum, providing limited information on their variability in leukocytes. Thus, the hypothesis of this study is that metabolic conditions, characterized by fasting or postprandial states, can influence the fatty acid profile depending on the blood fraction analyzed. To evaluate this hypothesis, six healthy individuals will be supplemented with fish oil for eight weeks, with blood samples collected before and after the intervention. Fatty acid levels will be measured using gas chromatography coupled with mass spectrometry in total plasma, phospholipids, erythrocytes, and leukocytes. The results will help estimate the variability caused by metabolic states according to the blood fraction, which is critical when conducting clinical trials in patients where fasting cannot be assured and is essential for comparing fatty acid profiles in studies involving leukocytes.",[29],[471,472,473,474],"EPA","DHA","supplementation","leukocytes",{"date":476,"type":41},"2024-12-12",{"date":478,"type":23},"2024-12-03",{"date":480,"type":23},"2025-03-30",{"name":456,"class":48}]