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NCT Number: NCT07769008

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Angiography (CAG) Coronary Artery Bypass Grafting Coronary Computed Tomography Angiography Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location status: Recruiting

Location contact

Yunpeng Zhu, MD

CONTACT

[email protected]

0086-02164370045

Yunpeng Zhu, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Referred to CABG treatment

Exclusion criteria

  • Under the age of 18 years
  • Unable to provide informed consent
  • Emergency CABG
  • Redo-CABG
  • Prior PCI with coronary stent implantation
  • Cardiogenic shock
  • Unable to undergo CAG or CCTA examination or deemed unsuitable by the investigator, such as:

Known allergy to iodinated contrast media; Active hyperthyroidism or uncontrolled thyroid disease; Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m²; Atrial fibrillation with rapid ventricular response or severe arrhythmias not amenable to rate control;

  • Pregnancy, lactation, or childbearing potential without effective contraception in female participants
  • Concurrent participation in another interventional trial

Treatment and study plan

CCTA-based CABG

Procedure

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

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.

Primary outcomes

  1. 1-year incidence of 5-Point Major Adverse Cardiovascular Events (5P-MACE)

    Time frame: Within 1 year post-CABG

    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. 1-year incidence of all-cause death

    Time frame: Within 1 year post-CABG

    inclduing all-cause death (as well as CV death), myocardial infarction, stroke, unplanned revascularization, and CABG-related or CV-related prolonged PLOS or rehospitalization.

  2. 1-year incidence of CV death

    Time frame: within 1 year post-CABG

    inclduing all-cause death (as well as CV death), myocardial infarction, stroke, unplanned revascularization, and CABG-related or CV-related prolonged PLOS or rehospitalization.

  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

  5. 1-year incidence of unplanned revascularization

    Time frame: Within 1 year post-CABG

  6. 1-year incidence of CABG-related or CV-related prolonged PLOS or rehospitalization.

    Time frame: Within 1 year post-CABG

  7. 30-day incidence of the operative mortality and morbidity

    Time frame: Within 30 days post-CABG

    The operative mortality and morbidity was defined as a composite of all-cause death, MI, stroke, unplanned revascularization, reoperation, prolonged ventilation (>24h, including tracheotomy or reintubation), deep sternal wound infection (DSWI), and new dialysis.

  8. 7-day graft failure rate

    Time frame: At 7 day post-CABG

    Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.

  9. 1-year graft failure rate

    Time frame: At 1 year post-CABG

    Graft failure defined as modified FitzGibbon grade B, S, or O, assessed by CCTA.

  10. Other serious adverse events (SAE)

    Time frame: Within 1 year post-CABG

    Important medical events that impact subjects' daily life or health and require appropriate intervention, but are not part of the primary or secondary outcome definitions above

Study contacts

Contact information is provided by the study sponsor or research team.

Yunpeng Zhu, MD

CONTACT

[email protected]

0086-02164370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Registry information

Official study title

Coronary Computed Tomography Angiography-Based Versus Coronary Angiography-Based Coronary Artery Bypass Grafting: A Multicenter Pragmatic Non-Inferiority Randomized Controlled Trial

Acronym: CtaCAB

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 17, 2026
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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