NCT06614023

Brief Summary

All consecutive patients who underwent isolated coronary artery bypass grafting (CABG) at our institution from 2014 to 2020 were included. Patients were divided into 6 groups according to body mass index (BMI): underweight (BMI \<20.0 kg/m2), normal weight (BMI 20.0-24.9 kg/m2), overweight (BMI, 25-29.9 kg/m2), obesity class I (BMI 30-34.9 kg/m2), obesity class II (BMI 35-39.9 kg/m2) and obesity class III (BMI \>40 kg/m2). The long-term mortality was analyzed as primary end-point. The univariable and multivariable analysis was performed using logistic regression modeling.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2024

Completed
24 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
Last Updated

September 26, 2024

Status Verified

August 1, 2024

Enrollment Period

6.8 years

First QC Date

September 2, 2024

Last Update Submit

September 23, 2024

Conditions

Keywords

body mass indexcoronary artery bypass graftingobesitymortality

Outcome Measures

Primary Outcomes (1)

  • long-term mortality

    2014-2022

Secondary Outcomes (1)

  • sternal wound infection rate

    2014-2022

Study Arms (6)

underweight

BMI \<20.0 kg/m2

Procedure: coronary artery bypass grafting

normal weight

BMI 20.0-24.9 kg/m2

Procedure: coronary artery bypass grafting

overweight

BMI 25-29.9 kg/m2

Procedure: coronary artery bypass grafting

obesity class I

BMI 30-34.9 kg/m2

Procedure: coronary artery bypass grafting

obesity class II

BMI 35-39.9 kg/m2

Procedure: coronary artery bypass grafting

obesity class III

BMI \>40 kg/m2

Procedure: coronary artery bypass grafting

Interventions

surgical coronary revascularization

normal weightobesity class Iobesity class IIobesity class IIIoverweightunderweight

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all consecutive patients undergoing isolated CABG

You may qualify if:

  • patients undergoing isolated CABG

You may not qualify if:

  • any concomitant additional surgical procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ObesityCoronary Artery DiseaseAngina PectorisIschemia

Interventions

Coronary Artery Bypass

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsPathologic Processes

Intervention Hierarchy (Ancestors)

Myocardial RevascularizationCardiac Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeVascular GraftingVascular Surgical ProceduresThoracic Surgical Procedures

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2024

First Posted

September 26, 2024

Study Start

January 1, 2014

Primary Completion

September 30, 2020

Study Completion

February 1, 2022

Last Updated

September 26, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share