About this trial
The goal of this clinical trial is to find out if using a non-invasive heart scan (called coronary computed tomography angiography, or CCTA) to plan coronary artery bypass grafting (CABG) works as well as the standard invasive approach (called coronary angiography, or CAG) for people with blocked heart arteries.
The main questions it aims to answer are:
Do people who have surgery planned with the non-invasive heart scan have similar health outcomes at 1 year as those who have surgery planned with the standard invasive approach? How does the non-invasive approach compare in terms of heart attacks, strokes, unplanned repeat procedures, and longer hospital stays? Researchers will compare two groups of participants. One group will have their surgery planned using only the CCTA . The other group will have their surgery planned using only the CAG. Both groups will undergo the CABG per local protocol.
Participants will:
Be randomly assigned (like flipping a coin) to one of the two planning approaches Undergo CABG as scheduled Return for follow-up visits at sugery days, 7 days, 1 month, 6 months, and 1 year after surgery Have a follow-up CCTA scan at 7 days and 1 year to check if the new bypass grafts are working well
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Referred to CABG treatment
Disqualifiers
Under the age of 18 years
Unable to provide informed consent
Emergency CABG
Redo-CABG
Trial design
Parallel
Treatments tested in this trial
CCTA-based CABG
Procedure/SurgerySurgical planning based solely on CCTA-derived data, including diameter stenosis (DS), area stenosis (AS), CT-derived fractional flow reserve (CT-FFR), LV:RV perfusion index, plaque characterization, 3D reconstruction of target vessels, and collateral circulation of chronic total occlusions (CTO) and so on. CCTA performed using photon-counting CT or conventional CT (≥64-slice, preferably ≥256-slice), following a standardized acquisition protocol. Images are transferred to an independent core laboratory for quantitative analysis and standardized reporting. The operating surgeon will not have access to CAG.
CAG-based CABG
Procedure/SurgerySurgical planning following standard practice using invasive coronary angiography(CAG). Angiograms obtained using a flat-panel detector system with standardized projections. The results of CAG are interpreted by the operating surgeon.The operating surgeon will not have access to CCTA.
Treatment groups
Trial outcomes
Primary outcomes
1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)
The 5P-MACE was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, and CABG-related or cardiovascular-related prolonged postoperative length of stay (PLOS) or rehospitalization.
Secondary outcomes
1-year incidence of all-cause death
1-year incidence of CV death
1-year incidence of MI
1-year incidence of stroke
Sponsors and contacts
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