Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06346145
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-15
Brief Title:
Impact of Bariatric Surgery on Heart Disease Compared to Standard Care
Sponsor:
Danderyd Hospital
Organization:
Danderyd Hospital
Study Overview
Official Title:
A Randomized Controlled Trial Comparing Metabolic Surgery to Standard Care in Patients With Severe Obesity and Established Cardiovascular Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MIMS
Brief Summary:
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 dieticianphysiotherapist 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-00453 | OTHER_GRANT | Swdeish research council | None |