CABG Based on CT-FFR Versus Conventional Coronary Angiography

NCT06028165 | Recruiting

• 1 other identifier: MyongjiH
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 1-Year graft patency rates

  postoperative graft patency measured by 1 year postoperative coronary angiography

  1 year

Secondary Outcomes (4)

• Overall survival

  4 years

• Freedom from Cardiac Death

  4 years

• Freedom From MACCE(Major Adverse Cardiac and Cerebrovascular Events)

  4 years

• Early Angiographic Patency Rates

  1.5 days

Study Arms (2)

CAG group

ACTIVE COMPARATOR

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

CT-FFR group

ACTIVE COMPARATOR

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.

Interventions

Coronary artery bypass grafting based on conventional coronary angiography PROCEDURE

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

CAG group

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

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

CT-FFR group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Myongji Hospital: lead

Study Sites (1)

Myongji Hospital

Goyang-si, Gyeonggi-do, South Korea

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Min-Seok Kim, MD, PhD, MSc

  Cardiovascular Center, Myongji Hospital

  STUDY CHAIR

Central Study Contacts

Min-Seok Kim, MD, PhD, MSc

CONTACT

82-10-8482-0380; minseok.kim.md.phd@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 8, 2023
• Study Start: October 20, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: July 5, 2024

Record last verified: 2024-07

Locations

KR (1)