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CABG Based on CT-FFR Versus Conventional Coronary Angiography

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ClinicalTrials.gov Identifier: NCT06028165
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : January 31, 2024
Sponsor:
Information provided by (Responsible Party):
Min-Seok Kim, Myongji Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Coronary artery bypass grafting based on conventional coronary angiography Procedure: Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve. Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: A Prospective, Randomized Comparison of Coronary Artery Bypass Grafting Based on COmputed Tomography-derived Fractional Flow REserve Versus Angiography (CABG-COREA Trial)
Actual Study Start Date : October 20, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CAG group
Patients who underwent coronary artery bypass grafting based on conventional coronary angiography
 Procedure: Coronary artery bypass grafting based on conventional coronary angiography
Revascularized coronary arteries are decided based on conventional coronary angiography.
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.


Outcome Measures
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Primary Outcome Measures :
  1. 1-Year graft patency rates [ Time Frame: 1 year ]
    postoperative graft patency measured by 1 year postoperative coronary angiography


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 4 years ]
    Overall survival rate at 4 years

  2. Freedom from Cardiac Death [ Time Frame: 4 years ]
    Freedom from cardiac death at 4 years

  3. 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. 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


Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06028165


Contacts
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Contact: Min-Seok Kim, MD, PhD, MSc 82-10-8482-0380 minseok.kim.md.phd@gmail.com

Locations
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Korea, Republic of
Myongji Hospital Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Min-Seok Kim, MD, PhD, MSc         
Sponsors and Collaborators
Myongji Hospital
Investigators
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Study Chair: Min-Seok Kim, MD, PhD, MSc Cardiovascular Center, Myongji Hospital
More Information
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Responsible Party: Min-Seok Kim, Associate Professor, Myongji Hospital
ClinicalTrials.gov Identifier: NCT06028165    
Other Study ID Numbers: MyongjiH
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: January 31, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is not yet known if there will be a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases