CABG Based on CT-FFR Versus Conventional Coronary Angiography

July 2, 2024 updated by: Min-Seok Kim, Myongji Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of
        • Recruiting
        • MyongJi Hospital
        • Contact:
          • Min-Seok Kim, MD, PhD, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CT-FFR group
Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve
Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.
Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.
Active Comparator: CAG group
Patients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography)
Procedure: Coronary artery bypass grafting based on conventional coronary angiography
Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-Year graft patency rates
Time Frame: 1 year
postoperative graft patency measured by 1 year postoperative coronary angiography
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)
Time Frame: 4 years
freedom from MACCE(major adverse cardiac and cerebrovascular events)at 4 years
4 years
Overall survival
Time Frame: 4 years
Overall survival rate at 4 years
4 years
Freedom from Cardiac Death
Time Frame: 4 years
Freedom from cardiac death at 4 years
4 years
Early Angiographic Patency Rates
Time Frame: 1.5 days
The patency rate of the grafts evaluated with coronary angiograms early after coronary artery bypass grafting
1.5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Myongji Hospital

Investigators

  • Study Chair: Min-Seok Kim, MD, PhD, MSc, Cardiovascular Center, Myongji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 20, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 5, 2023

First Posted (Actual)

September 8, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MyongjiH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe