## Protocol Section
### Identification Module
**NCT ID:** NCT06420479

**Brief Title:** The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

**Official Title:** The Causal Effect of Bariatric Surgery on Cardiovascular Disease and Mortality

#### Organization Study ID Info
**ID:** 2024-00558-01
#### Organization
**Class:** OTHER
**Full Name:** Karolinska Institutet
### Status Module
#### Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Karolinska Institutet

#### Responsible Party

**Investigator Affiliation:** Karolinska Institutet

**Investigator Full Name:** Conor Macdonald

**Investigator Title:** Dr.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** The association between weight, and cardiovascular disease and mortality is well established, however, the causal effect of weight-loss in midlife on these outcomes is less clear. Bariatric surgery results in substantial weight-loss and is an ideal candidate to study the causal effects of weight-loss. We propose a project that will use causal inference and machine learning methods to answer two important questions:

1. Is bariatric surgery effective for reducing cardiovascular disease and mortality, and if so, for who?
2. Which type of bariatric surgery (gastric bypass or sleeve gastrectomy) is most effective, and for who? We will use data from various Swedish registers to identify individuals with obesity who are eligible for bariatric surgery. We will then compare cardiovascular and mortality outcomes among those undergoing different types of bariatric surgery with those receiving non-surgical obesity management using causal inference methods. We will use causal forests and expert knowledge to estimate indiviual treatment effects, and identify the groups of patients who benefit the most from these surgeries.

### Conditions Module

**Conditions:**

- Bariatric Surgery Candidate

- Cardiovascular Diseases

- Morality

**Keywords:**

- bariatric surgery

- Cardiovascular Diseases

- Mortality

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 20 Years

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** A well-known intervention known to induce substantial weight loss

**Name:** Bariatric surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** myocardial infarction, stroke, and death from cardiovascular causes

**Measure:** Cardiovascular disease

**Time Frame:** 20 year

#### Secondary Outcomes

**Measure:** Death from any cause

**Time Frame:** 20 year

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Men and women of reproductive age with a diagnosis of obesity, no prior history of cardiovascular disease or cancer, and no contraindications for surgery after 1982

Exclusion Criteria:

* Contraindications to bariatric surgery

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** A cohort of individuals eligible for bariatric surgery in Sweden

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** conor.macdonald@ki.se

**Name:** Conor MacDonald, PhD

**Phone:** 0000

**Phone Ext:** 000

**Role:** CONTACT

**Contact 2:**

**Email:** anita.berglund@ki.se

**Name:** Anita Berglund, PhD

**Phone:** 0000

**Phone Ext:** 000

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Stockholm

**Contacts:**

***Contact 1:***

- **Email:** conor.macdonald@ki.se

- **Name:** Conor MacDonald, PhD

- **Phone:** 0000

- **Phone Ext:** 000

- **Role:** CONTACT

***Contact 2:***

- **Email:** anita.berglund@ki.se

- **Name:** Anita Berglund, PhD

- **Phone:** 0000

- **Phone Ext:** 000

- **Role:** CONTACT

**Country:** Sweden

**Facility:** Karolinska Institutet

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

### Misc Info Module

- Version Holder: 2024-05-31
