Impact of Body Weight on Outcomes of Patients Undergoing Coronary Artery Bypass Grafting

NCT ID: NCT06614023

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

6448 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2022-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

All consecutive patients aged above eighteen who underwent isolated CABG were enrolled. Patients operated on- and off-pump were included. We reviewed elective, urgent, emergency and salvage surgeries. Patients with any additional concomitant surgical procedures were excluded.

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 primary endpoint was long-term mortality. The secondary end-point was the rate of sternal wound infections.

Summary statistics were calculated. Continuous data are described as the median, with the interquartile range in parentheses, while categorical data are shown as numbers with percentages. Differences between groups for normally distributed, continuous variables were determined using the one-way analysis of variance with Holm-Sidak post-hoc test. The Kruskal Wallis test was used for the analysis of non-normally distributed continuous variables with Dunn's test for post hoc comparison. The chi-squared test was used for the analysis of categorical variables. Bonferoni's correction was used for post-hoc analysis. The univariable analysis was performed using logistic regression. For multivariable analysis a logistic regression model was performed, with mortality or wound infection as the dependent variable, and all other characteristics summarized in the table 1 as independent variables. The backward conditional selection was used for modeling with variables with score statistics \<0.1 included in the model. Significance was assessed at p\<0.05. Multiple imputation was not used to adjust for missing data. The number of valid entries for each variable and alterations in the sample size for specific analyses are described.

Analyses were performed using IBM SPSS Version 22.0 and MedCalc Version 19.4.1.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Coronary Artery Disease Angina Pectoris Coronary; Ischemic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

underweight

BMI \<20.0 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

normal weight

BMI 20.0-24.9 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

overweight

BMI 25-29.9 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

obesity class I

BMI 30-34.9 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

obesity class II

BMI 35-39.9 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

obesity class III

BMI \>40 kg/m2

coronary artery bypass grafting

Intervention Type PROCEDURE

surgical coronary revascularization

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

coronary artery bypass grafting

surgical coronary revascularization

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients undergoing isolated CABG

Exclusion Criteria

any concomitant additional surgical procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BNW-1-065/N/3/K

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.