[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480091":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":45,"responsibleParty":65,"collaborators":25,"id":67,"slug":25,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":25,"overallStatus":48,"whyStopped":25,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Population Health Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medical Weight Management","ACTIVE_COMPARATOR","MWM corresponds to standard medical practice for weight loss that is available at the local participating centre, and thus reflects the local standard of care. MWM will typically consist of dietary, lifestyle and\u002For behavioral modification counseling, which may include nutritional counseling, safe weight management and\u002For making healthy lifestyle changes. MWM may also include the implementation of a low caloric diet, which may comprise the use of adjuvant meal replacements and\u002For anti-obesity mediations at the discretion of the treating physician and according to local practice guidelines.",[13],"Behavioral: Medical Weight Management",{"label":15,"type":16,"description":17,"interventionNames":18},"Bariatric Surgery","EXPERIMENTAL","The bariatric surgery procedures performed in BRAVE include either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards. Sleeve gastrectomy will be performed as a stand-alone procedure, but may also be performed as part of a planned duodenal switch. Gastric banding is not permitted. Patients may receive a low fat, high protein meal replacement preceding surgery to reduce the size of the liver. Perioperative use of aspirin, thienopyridines (clopidogrel, ticagrelor or prasugrel), and anti-thrombotic therapy (compression stockings and subcutaneous heparin) should follow local guidelines and will be left at the discretion of the individual surgeons. .",[19],"Procedure: Bariatric Surgery",[21,26],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Bariatric surgery involves either gastric bypass, sleeve gastrectomy, or duodenal switch, performed at the discretion of the surgeon and according to local practice standards.",[15],null,{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":25},"BEHAVIORAL","The current standard medical practice for weight loss that is available at the local participating centre, reflecting the local standard of care",[9],[31],{"name":32,"affiliation":5,"role":33},"Salim Yusuf, DPhil, DSc (Oxon), FRCPC, FRSC","PRINCIPAL_INVESTIGATOR",[35,41],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Jorge Wong, MD, MPH, FRCPC","CONTACT","905-521-2100","40309","jorge.wong@phri.ca",{"name":42,"role":37,"phone":43,"phoneExt":25,"email":44},"Sumathy Rangarajan, MSc","905-296-5792","sumathy.rangarajan@phri.ca",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Hamilton Health Sciences","RECRUITING","Hamilton","Ontario","L8L 2X2","Canada","CA",{"type":55,"coordinates":56},"Point",[57,58],-79.84963,43.25011,{"lat":58,"lon":57},[61],{"name":62,"role":37,"phone":63,"phoneExt":64,"email":40},"Jorge Wong, MD","905-527-4322","41149",{"type":66,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100480091",false,"NCT05531474","Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial","BRAVE","Inclusion Criteria:\n\n1. Body mass index ≥30 kg\u002Fm2; OR BMI ≥30 kg\u002Fm2 to 34.9 kg\u002Fm2 and have type 2 diabetes or are \\>55 years of age\n2. Age ≥18 years\n3. High-risk CVD, defined as the presence of any one of the following:\n\n   1. High-risk coronary artery disease (CAD) (i.e., history of MI, percutaneous coronary intervention, coronary artery bypass grafting, or stenoses ≥ 50% in 2 or more major coronary arteries)\n   2. Left ventricular ejection fraction (LVEF) \\< 40%\n   3. Heart failure with preserved ejection fraction (LVEF \\> 40%) and either HF hospitalization in the last 2-years or N-terminal pro b-type natriuretic peptide (NT-proBNP) \\> 300 pg\u002Fml or BNP \\> 100 pg\u002Fml in the past 12 months\n   4. Documented atrial fibrillation (AF) with CHA2DS2-VASc ≥2 stroke risk score\n   5. History of any stroke\n   6. Documented peripheral arterial disease (PAD) (i.e., peripheral revascularization of the iliac, infra-inguinal or carotid arteries; limb or foot amputation for arterial vascular disease; or ≥50% carotid or peripheral artery stenosis)\n\nExclusion Criteria:\n\n1. Hospital admission for HF, myocardial infarction, stroke or coronary revascularization within 30 days of randomization\n2. Percutaneous coronary intervention with a drug eluting stent within 90 days of randomization.\n3. Pregnancy\n4. Contraindication to bariatric surgery\n5. Prior bariatric surgery, other than gastric banding\n6. Life expectancy \\<2 years from non-cardiovascular causes\n7. Inability to provide informed consent","ALL","18 Years",{"count":76,"type":77},700,"ESTIMATED","INTERVENTIONAL",[80],"NA","The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg\u002Fm2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.",[83,84],"Cardiovascular Complication","Bariatric Surgery Candidate","2026-05-25",{"date":87,"type":88},"2026-05-28","ACTUAL",{"date":90,"type":88},"2020-11-02",{"date":92,"type":77},"2027-07-01",{"name":5,"class":6},1]