Sex-related Differences in Outcome After Hybrid Coronary Revascularization

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06023355
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD). Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Detailed Description

Hybrid coronary revascularization (HCR) has emerged as a favorable technique over traditional coronary artery bypass grafting (CABG) in a select group of patients with multivessel coronary artery disease (CAD).

Till date, multiple individual studies comparing HCR with CABG have been carried out, but no data on the potential impact of sex on the outcome of HCR exist. Limited by their sample size, these individual studies may have been under-powered to detect a difference.

To fill this knowledge gap, the investigators aim to perform an international collaborative multi-center study in order to examine gender differences in short-term and long-term outcomes among patients who underwent HCR or CABG.

Study Timeline

• Study First Submitted: 2023-08-28
• Study First Submitted QC: 2023-08-28
• Study First Posted: 2023-09-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-29
• Study Start: 2024-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Patients with coronary artery disease and indication to cardiac surgery

Exclusion Criteria

Contraindications to cardiac surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Composite End-point	Up to 1 year	Cardiac death, myocardial infarction, stroke, bleeding
Incidence of Overall Mortality	Up to 1 year	All causes deaths