[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542690":3},{"organization":4,"outcomesModule":7,"designInfo":50,"detailedDescription":53,"studyPopulation":53,"armGroups":57,"interventions":69,"overallOfficials":77,"centralContacts":82,"locations":53,"responsibleParty":87,"collaborators":90,"id":96,"slug":53,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":53,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":53,"overallStatus":117,"whyStopped":53,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":53},{"fullName":5,"class":6},"Danderyd Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"MACE defined as first occurrence of death (all-cause mortality), MI, stroke, myocardial revascularization (not related to MI), hospital admission because of heart failure or atrial fibrillation as a primary ICD diagnosis.","Data will be obtained for the Swedish national patient registry and other national quality registries.","Through study completion, expected average of 6 years",[14,17,20,22,25,27,29,31,33],{"measure":15,"description":16,"timeFrame":12},"Total event rate","Based on events listed in the primary outcome measure. Data will be obtained for the Swedish national patient registry and other national quality registries.",{"measure":18,"description":19,"timeFrame":12},"All-cause mortality","Data will be obtained for the Swedish national national quality registries.",{"measure":21,"description":19,"timeFrame":12},"Cardiovascular death",{"measure":23,"description":24,"timeFrame":12},"Remission of type 2 diabetes (T2D) and hypertension","Number of patients in remission",{"measure":26,"description":19,"timeFrame":12},"Myocardial infarction",{"measure":28,"description":19,"timeFrame":12},"Stroke",{"measure":30,"description":19,"timeFrame":12},"Myocardial revascularization (not related to MI)",{"measure":32,"description":19,"timeFrame":12},"hospital admission because of heart failure as a primary ICD diagnosis.",{"measure":34,"description":19,"timeFrame":12},"hospital admission because of atrial fibrillation as a primary ICD diagnosis.",[36,38,42,45,48],{"measure":37,"description":11,"timeFrame":12},"Safety, i.e., no excess of severe complications (Clavien-Dindo ≥3b (a complication requiring intervention under general anesthesia or resulting in organ failure or death)) and long-term morbidity.",{"measure":39,"description":40,"timeFrame":41},"Body weight change","Change in kg from baseline during long-term follow-up.","5-year follow-up",{"measure":43,"description":44,"timeFrame":41},"Change in quality of life","Assessed by EQ-5D-5L questionnaire",{"measure":46,"description":47,"timeFrame":12},"All-cause hospitalizations","Based on ICD 10 diagnosis in national patient registry and other national quality registries",{"measure":43,"description":49,"timeFrame":41},"Assessed by RAND 36",{"allocation":51,"interventionModel":52,"interventionModelDescription":53,"primaryPurpose":54,"observationalModel":53,"timePerspective":53,"maskingInfo":55},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":56,"maskingDescription":53,"whoMasked":53},"NONE",[58,64],{"label":59,"type":60,"description":61,"interventionNames":62},"Bariatric surgery","ACTIVE_COMPARATOR","Gastric bypass or gastric sleeve",[63],"Procedure: Bariatric surgery",{"label":65,"type":60,"description":66,"interventionNames":67},"Standard care","Standard obesity treatment offered in Swedish regions",[68],"Procedure: Standard care",[70,74],{"type":71,"name":59,"description":72,"armGroupLabels":73,"otherNames":53},"PROCEDURE","Type of surgery assigned by surgeon in consultation with patient",[59],{"type":71,"name":65,"description":75,"armGroupLabels":76,"otherNames":53},"Standard care can consist of dietary intervention, physiotherapy or drug treatment in accordance to the care given in the region of Sweden where the patient resides.",[65],[78],{"name":79,"affiliation":80,"role":81},"Erik Näslund, MD, PhD","Karolinska Institutet\u002FDanderyd hospital","PRINCIPAL_INVESTIGATOR",[83],{"name":79,"role":84,"phone":85,"phoneExt":53,"email":86},"CONTACT","46812355017","Erik.Naslund@ki.se",{"type":81,"investigatorFullName":88,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Erik Näslund","Professor",[91,93],{"name":92,"class":6},"Karolinska Institutet",{"name":94,"class":95},"The 21 healthcare regions in Sweden","UNKNOWN","100542690",false,"NCT06346145","Impact of Bariatric Surgery on Heart Disease Compared to Standard Care","A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease","MIMS","Inclusion Criteria:\n\n* MI (as defined by the universal definition of MI) at least 1 year before inclusion.\n* BMI ≥35 kg\u002Fm2\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Any condition that may influence the patient's ability to comply with study protocol.\n* Earlier MBS or operation for gastric or duodenal ulcer or reflux disease\n* Other condition that makes patient not suitable for MBS according to responsible surgeon and anesthesiologist\n* Unable to understand Swedish.","ALL","18 Years","70 Years",{"count":107,"type":108},500,"ESTIMATED","INTERVENTIONAL",[111],"NA","Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician\u002Fphysiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.",[114,115,116],"Obesity, Morbid","Bariatric Surgery Candidate","Heart Diseases","NOT_YET_RECRUITING","2024-03-28",{"date":120,"type":121},"2024-04-03","ACTUAL",{"date":123,"type":108},"2024-05-01",{"date":125,"type":108},"2030-05-01",{"name":5,"class":6}]