CCTA-Based vs CAG-Based CABG: A Multicenter Pragmatic Non-Inferiority Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

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 volunteers

Qualifiers

Referred to CABG treatment

Disqualifiers

Under the age of 18 years

Unable to provide informed consent

Emergency CABG

Redo-CABG

Trial design

Design model

Parallel

Treatments tested in this trial

  • CCTA-based CABG

    Procedure/Surgery

    Surgical 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/Surgery

    Surgical 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

826 Participants
are divided into 2 treatment groups
Group A: CCTA-Based CABGExperimental treatment 1 intervention
Group B: CAG-Based CABGActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Within 1 year post-CABG

Secondary outcomes

1

1-year incidence of all-cause death

Time frame
Within 1 year post-CABG
2

1-year incidence of CV death

Time frame
within 1 year post-CABG
3

1-year incidence of MI

Time frame
Within 1 year post-CABG
4

1-year incidence of stroke

Time frame
Within 1 year post-CABG

Other outcomes

Sponsors and contacts

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