[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"major-cardiovascular-event\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:major-cardiovascular-event":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,48,83,119],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100538810","a-study-assessing-repatha-in-combination-with-standard-of-care-soc-compared-with-soc-on-major-cardiovascular-events-in-chinese-participants-with-atherosclerotic-cardiovascular-disease-100538810",false,"NCT06295679","A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease","A Real-world, Prospective, Observational Study Assessing the Effectiveness of Repatha® Used in Combination With Standard of Care Compared With Standard of Care Alone on Major Cardiovascular Events in Chinese Patients With Established Atherosclerotic Cardiovascular Disease","Inclusion Criteria:\n\n* Adult participants ≥ 18 years of age.\n* Participants or participant's legally authorized representative has provided informed consent to participate in this study.\n* Participants who meet one of the following:\n* Prescribed Repatha® in addition to an existing SOC treatment according to local guidelines and approved label.\n\nOR\n\n* Already received SOC treatment prior to enrollment.\n* Participants with ANY of the following.\n* Diagnosis of MI OR stroke within 2 years before enrollment.\n* 2 MIs OR ≥ 2 strokes OR (≥ 1 MI AND ≥ 1 stroke) any time before enrollment.\n* Diagnosis of (MI OR stroke) AND diabetes.\n* Diagnosis of (MI OR stroke) AND documented multivessel disease (defined as \\> 50% stenosis of ≥ 2 major coronary arteries on coronary angiography or coronary artery contrast enhanced computed tomography).\n* Diagnosis of symptomatic peripheral arterial disease.\n* Most recent fasting LDL-C ≥ 70 mg\u002FdL (≥ 1.8 mmol\u002FL) or nonhigh-density lipoprotein cholesterol (non-HDL-C) ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL) within 6 months prior to enrollment.\n* Most recent fasting triglycerides ≤ 400 mg\u002FdL (≤ 4.5 mmol\u002FL) within 6 months prior to enrollment.\n\nExclusion Criteria:\n\n* Stroke within past 1 month.\n* Known hemorrhagic stroke at any time.\n* Stroke due to thromboembolic event.\n* Any prior use of Repatha® or other proprotein convertase subtilisin\u002Fkexin type 9 inhibition treatments within past 6 months prior to enrollment.\n* Participants currently enrolled in another study involving any investigational procedure, device or drug.\n* Participants prescribed Repatha® with a history of severe hypersensitivity or allergy to any subsidiary.","ALL","18 Years","150 Years",{"count":20,"type":21},7000,"ESTIMATED","OBSERVATIONAL","The primary objective of the study is to evaluate real-world effectiveness of treatment with Repatha® in combination with SOC, compared with SOC alone, on the risk for cardiovascular (CV) death, myocardial infarction (MI), stroke, hospitalization for unstable angina, or coronary revascularization, whichever occurs first, in participants with established atherosclerotic CV disease (ASCVD) treated with SOC, according to local clinical practice.",[25,26],"Major Cardiovascular Event","Established Atherosclerotic Cardiovascular Disease",[28,29,30,31,32,33,34],"Cardiovascular death","Myocardial infarction","Stroke","Unstable angina","Coronary revascularization","Atherosclerotic Cardiovascular Disease","Repatha","RECRUITING","2026-06-24",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":39},"2022-12-19",{"date":43,"type":21},"2028-12-19",{"name":45,"class":46},"Amgen","INDUSTRY",90,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":57,"phases":58,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":4},"100620611","phase-1-relaxin-therapy-for-atrial-fibrillation-100620611","NCT07359872","Relaxin Therapy for Atrial Fibrillation","Relax-in-AF","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosed with AF and scheduled for elective catheter ablation for AF\n\nExclusion Criteria:\n\n* Enrollment in another Greater than Minimal Risk Study\n* Pregnant, nursing, or sexually active females not using birth control or having been surgically sterilized\n* Females who plan to become pregnant during the trial period\n* Patients diagnosed with \"permanent\" AF, complete heart block, or a reversible cause of AF (e.g., transient thyrotoxicosis)\n* Patients that require antiarrhythmic medication to started or continued during and after the ablation procedure.\n* Patients unable to tolerate Relaxin therapy or unable or unwilling to provide informed consent",{"count":56,"type":21},208,"INTERVENTIONAL",[59,60],"PHASE1","PHASE2","Atrial fibrillation (AF) is the most common heart rhythm disorder. The presence of AF increases the risk of death and is associated with a 5-6-fold increase in stroke incidence, due almost exclusively to thrombus formation in the heart. Current therapies for AF are limited. The evaluation of new, more effective treatments for preventing AF recurrence remains a critical unmet clinical need. AF is considered a progressive disease that increases in prevalence with age and can convert from \"paroxysmal\" to \"persistent\" to \"permanent\" AF in a single individual. This progression results, in part, from high oxidative stress and progressive adverse electrical changes in the heart. Compelling preclinical and clinical data indicate that Relaxin, a naturally occurring peptide hormone, may reverse the electrical remodeling. Thus, our overall objective is to investigate the effects of Relaxin in Veterans who have failed medical management for symptomatic AF and is referred to Cardiac Electrophysiology Laboratory for catheter ablation and pulmonary vein isolation. We will determine whether Relaxin therapy, in addition to the standard of care, counteracts the oxidative stress-related electrical derangement and reduces the post-ablation AF burden. A unique aspect of this proposal is that it is based in part on observations derived from the basic, translational and computational labs of the PI and co-investigators and from the observations by the PI while caring for patients with AF. As such, this proposal represents a true progression from the bench to the bedside. If successful, our findings may lead to the design of a new, more effective treatment for a major unmet public health problem in the United States as well as the world.",[63,64,65,30,25,66,67,68],"Atrial Fibrillation (AF)","Arrhythmia","Oxidative Stress","Heart Failure","Catheter Ablation","Ablation of Atrial Fibrillation",[70,71],"randomized controlled crossover trial","Randomized clinical trial","NOT_YET_RECRUITING","2026-01-21",{"date":75,"type":39},"2026-01-22",{"date":77,"type":21},"2027-01-01",{"date":79,"type":21},"2030-12-31",{"name":81,"class":82},"Deeptankar DeMazumder","FED",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":57,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":118},"100586740","the-effect-of-a-digital-heart-health-app-and-lifestyle-intervention-for-heart-disease-in-primary-care-100586740","NCT06919302","The Effect of a Digital Heart Health App and Lifestyle Intervention for Heart Disease in Primary Care.","An Innovative Technology-based Approach to Translating Clinical Practice Guidelines of Nutrition Therapy in Primary Care: The Coronary Heart Effectiveness Assessment of the Portfolio Diet in Primary Care (CHEAP) Trial","CHEAP","Inclusion Criteria:\n\n* Be taking statin medication with or without other antihyperlipidemic therapy (stable dose for at least 3-months).\n* Fall under either of the 2 categories:\n\n  1\\) Secondary prevention participants: males and females ≥45 years of age with established atherosclerotic cardiovascular disease (ASCVD) defined as at least one of the following: i. Prior myocardial infarction (MI); ii. Acute coronary syndrome (ACS); iii. Stroke\u002FTIA; iv. Coronary revascularization; v. Documented carotid disease (endarterectomy, carotid stenosis ≥50%); vi. Stable angina; vii. Coronary artery disease (CAD) by angiography; viii. Peripheral artery disease (PAD); ix. Abdominal aortic aneurysm (AAA)\n\n  2\\) High-risk primary prevention participants: males and females ≥50 years of age plus type 2 diabetes requiring treatment with medication and at least one additional risk factor: i. Males ≥55 years of age and females ≥65 years of age; ii. Cigarette smoker or stopped smoking within 3 months before Visit 1; iii. Hypertension and on antihypertensive medication for at least 6-months; iv. Chronic kidney disease (CKD); v. Retinopathy, defined as any of the following: non-proliferative retinopathy, pre-proliferative retinopathy, proliferative retinopathy, maculopathy, advanced diabetic eye disease or a history of photocoagulation\n* Be on a stable dose for at least 3-months of all antihyperlipidemic, antihyperglycemic, antihypertensive, and antiobesity therapies.\n* Have a family physician in Ontario and a valid Ontario Health Card.\n* Have regular access to an online portal\n* Be proficient in English.\n\nExclusion Criteria:\n\n* Major disease expected to result in death within 2 years (except cardiovascular disease)\n* Active sever liver disease\n* Malabsorption disorders\n* Drug or alcohol abuse disorders (within past 6 months)\n* Intolerance or allergies to soy protein and tree nuts, peanuts, or seeds\n* Planned coronary intervention or any major surgical procedure\n* Participation in another clinical trial (within past 3 months)\n* End stage renal disease (requirement for peritoneal dialysis or hemodialysis for renal insufficiency or eGFR \\\u003C30 mL\u002Fmin)\n* Any condition or therapy which might pose a risk to the patient or make participation in the study not be in the best interest of the patient as assessed by the investigator\n* Documented severe (New York Heart Association \\[NYHA\\] class IV) heart failure\n* Mental\u002Fpsychological impairment expected to affect adherence to the study protocol\n* Known AIDS (HIV-positive patients without AIDS are allowed)\n* Women planning on becoming pregnant within the first year of the intervention\n* Unable to provide informed consent: Appear unable to comprehend the study protocol during the interview process or to understand and communicate in English sufficiently for informed consent.","45 Years",{"count":93,"type":21},1100,[95],"NA","Despite the availability of medications, many people around the world continue to live with long-term health problems like heart disease, stroke and diabetes. In Canada, heart disease is a leading cause of death. Managing these health issues can be done by changing diet and lifestyle. Specific ways of eating have been proven to improve risk for heart disease and stroke. However, because doctors often have limited time, nutrition education, and lack of tools for counseling patients on nutrition, they can often only provide minimal support to help patients make necessary lifestyle changes. Digital tools and mobile applications offer an opportunity to involve doctors and patients in delivering nutrition interventions. This approach has the potential to save time, provide education, and reduce healthcare costs. This study is being done to understand the effect of a digital heart health program added to standard of care, compared with standard of care alone on heart health. All eligible participants in this study will be randomized (determined by chance) to one of two possible interventions: 1) a digital heart health program + standard of care; 2) standard of care. Standard is care is defined as the best practice based on guidelines for the treatment of a condition. All participants will be followed for seven years and will be asked to complete online questionnaires and complete blood work at their nearest LifeLabs clinic, as well as wear a continuous glucose monitor and wrist actigraph (at 3 time points in the first year). In addition, participants randomized to the digital heart health program + standard of care will be expected to use the heart health app and join 16 online synchronous sessions over the first year.\n\nAfter seven years, the intervention phase of the study will end and the study will become a cohort study. All participants at the 7-year time point will be invited to use the heart health app. As part of the cohort study, participants will be asked to continue completing the same questionnaires online and completing bloodwork at their nearest LifeLabs every four years for the duration of their participation in the cohort study.\n\nThe main questions this study aims to answer are:\n\n1. Will a digital heart health program added to standard of care result in a clinically meaningful reduction in blood cholesterol and other risk factors after 1-year compared to standard of care alone?\n2. Will a digital heart health program added to standard of care result in a reduction in major cardiovascular events after 7-years compared to standard of care alone?\n3. Are the observed effects sustained beyond the 7-years of the intervention?\n\nWe hypothesize that the digital heart health program added to standard of care will result in a clinically meaningful reduction in blood cholesterol and other risk factors for heart disease after 1-year and reduce major cardiovascular events after 7-years compared to standard of care alone.",[98,99,100,101,25],"Cardiovascular Diseases","Cardiovascular Risk Factors","Dyslipidemia","Cholesterol",[103,104,105,106,107],"randomized controlled trial","digital heart health program","heart health app","web-based app","large-scale study","2025-11-20",{"date":110,"type":39},"2025-11-26",{"date":112,"type":39},"2025-08-15",{"date":114,"type":21},"2035-06-01",{"name":116,"class":117},"University of Toronto","OTHER",1,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":144},"100575629","use-of-machine-learning-algorithms-biomarkers-and-measures-of-quality-of-life-to-personalize-medical-management-of-liver-and-heart-transplant-recipients-100575629","NCT06774768","Use of Machine-learning Algorithms, Biomarkers and Measures of Quality of Life to Personalize Medical Management of Liver and Heart Transplant Recipients","DARE","Retrospective cohort Inclusion criteria Receiving a heart or liver transplantation at IRCCS AOUBO between January 2008 and December 2020.\n\nSurviving at least 6 months after surgery Receiving at least one outpatient clinical assessment, comprising clinical evaluation, standard laboratory tests, and graft ultrasound Older than 18 years old\n\nExclusion criteria Unavailability of medical records in the standard data repositories of IRCCS AOUBO\n\nProspective cohort\n\nInclusion criteria Older thant 18 years old Receiving a heart or liver transplantation at least 6 months before study entry and being in active follow up at IRCCS AOUBO Obtaining informed consent\n\nExclusion criteria None",{"count":127,"type":21},1000,"This is an observational, low risk tissue based, non-pharmacological, retrospective-prospective study for adults heart and liver transplant patients, related to IRCCS Azienda Ospedaliero-Universitaria di Bologna (IRCCS AOUBO).\n\nThis clinical study is part of the national multicentric project DARE. The project has the wide overarching aim to develop digital solutions for personalized healthcare.",[130,131,132,133,134,25],"Artificial Intelligence (AI)","Hepatocellular Carcinoma (HCC)","Heart Transplantation","Liver Transplantation","Machine Learning","2025-01-09",{"date":137,"type":39},"2025-01-14",{"date":139,"type":21},"2025-01-30",{"date":141,"type":21},"2029-12-31",{"name":143,"class":117},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",2]