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Clinical Trials/NCT06028165
NCT06028165
Recruiting
N/A

A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)

Myongji Hospital1 site in 1 country96 target enrollmentOctober 20, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Myongji Hospital
Enrollment
96
Locations
1
Primary Endpoint
1-Year graft patency rates
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aims of study are (1) to compare early and 1-year graft patency rates in patients who underwent coronary artery bypass grafting (CABG) based on conventional coronary angiography(CAG) versus cardiac computed tomography(CT)-derived fractional flow reserve(FFR), and (2) to demonstrate difference in clinical outcomes between the 2 groups.

Detailed Description

The CABG-COREA trial is designed as a randomized, controlled trial to recruit 96 patients who undergo coronary artery bypass grafting. Patients were randomized by use of a randomization table. Coronary arteries are revascularized based on conventional coronary angiography (quantitative coronary angiography) or cardiac computed tomography-derived fractional flow reserve according to the randomization result. The primary end point is to evaluate early and 1-year postoperative graft patency. The secondary end points are overall survival, freedom from cardiac death and freedom from MACCE(major adverse cardiac or cerebrovascular events).

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
October 1, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Min-Seok Kim

Associate Professor

Myongji Hospital

Eligibility Criteria

Inclusion Criteria

  • age equal or more than 40
  • age equal or less than 80
  • patients who undergo coronary artery bypass grafting due to multi-vessel coronary artery disease
  • patients who agree to the enrollment

Exclusion Criteria

  • Patients with heart failure (left ventricular ejection fraction \< 25%)
  • patients who have intractable ventricular arrhythmia
  • patients who has been treated for cancer
  • patients who has infectious disease
  • patients who are planned to undergo combined cardiac surgery
  • patients who has medical co-morbidity with expected survival less than 1 year
  • patients with a history of previous cardiac surgery
  • Patients with chronic renal failure requiring dialysis
  • patients who undergo emergency operation

Outcomes

Primary Outcomes

1-Year graft patency rates

Time Frame: 1 year

postoperative graft patency measured by 1 year postoperative coronary angiography

Secondary Outcomes

  • Early Angiographic Patency Rates(1.5 days)
  • Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)(4 years)
  • Overall survival(4 years)
  • Freedom from Cardiac Death(4 years)

Study Sites (1)

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