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