protocolSection identificationModule nctId: NCT06346145, orgStudyIdInfo id: MIMS study, secondaryIdInfos id: 2023-00453, type: OTHER_GRANT, domain: Swdeish research council, briefTitle: Impact of Bariatric Surgery on Heart Disease Compared to Standard Care, acronym: MIMS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2028-05-01, completionDateStruct date: 2030-05-01, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: The 21 healthcare regions in Sweden, descriptionModule briefSummary: 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/physiotherapist). 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., conditionsModule conditions: Obesity, Morbid, conditions: Bariatric Surgery Candidate, conditions: Heart Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Bariatric surgery, interventions name: Standard care, outcomesModule primaryOutcomes measure: 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., secondaryOutcomes measure: Total event rate, secondaryOutcomes measure: All-cause mortality, secondaryOutcomes measure: Cardiovascular death, secondaryOutcomes measure: Remission of type 2 diabetes (T2D) and hypertension, secondaryOutcomes measure: Myocardial infarction, secondaryOutcomes measure: Stroke, secondaryOutcomes measure: Myocardial revascularization (not related to MI), secondaryOutcomes measure: hospital admission because of heart failure as a primary ICD diagnosis., secondaryOutcomes measure: hospital admission because of atrial fibrillation as a primary ICD diagnosis., otherOutcomes measure: 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., otherOutcomes measure: Body weight change, otherOutcomes measure: Change in quality of life, otherOutcomes measure: All-cause hospitalizations, otherOutcomes measure: Change in quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False