CABG Based on CT-FFR Versus Conventional Coronary Angiography

NCT ID: NCT06028165

Last Updated: 2024-07-05

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-10-01

Brief Summary

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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

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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).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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CAG group

Patients who underwent coronary artery bypass grafting based on conventional coronary angiography (quantitative coronary angiography)

Group Type ACTIVE_COMPARATOR

Coronary artery bypass grafting based on conventional coronary angiography

Intervention Type PROCEDURE

Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)

CT-FFR group

Patients who underwent coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve

Group Type ACTIVE_COMPARATOR

Coronary artery bypass grafting based on cardiac computed tomography-derived fractional flow reserve.

Intervention Type PROCEDURE

Revascularized coronary arteries are decided based on cardiac computed tomography-derived fractional flow reserve.

Interventions

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Coronary artery bypass grafting based on conventional coronary angiography

Revascularized coronary arteries are decided based on conventional coronary angiography (quantitative coronary angiography)

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Min-Seok Kim

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Min-Seok Kim, MD, PhD, MSc

Role: STUDY_CHAIR

Cardiovascular Center, Myongji Hospital

Locations

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Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Min-Seok Kim, MD, PhD, MSc

Role: CONTACT

82-10-8482-0380

Facility Contacts

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Min-Seok Kim, MD, PhD, MSc

Role: primary

Other Identifiers

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MyongjiH

Identifier Type: -

Identifier Source: org_study_id

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