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

NCT07769008 | Recruiting DMC

• 1 other identifier: KY-2026-523
• Study Type: interventional
• Target: 826
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease; Coronary Artery Bypass Grafting; Coronary Computed Tomography Angiography; Coronary Angiography (CAG)

Keywords

Major Adverse Cardiovascular Events (MACE); Coronary Artery Bypass Grafting (CABG); Coronary Computed Tomography Angiography(CCTA); Coronary Angiography(CAG)

Outcome Measures

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.

  Within 1 year post-CABG

Secondary Outcomes (10)

• 1-year incidence of all-cause death

  Within 1 year post-CABG

• 1-year incidence of CV death

  within 1 year post-CABG

• 1-year incidence of MI

  Within 1 year post-CABG

• 1-year incidence of stroke

  Within 1 year post-CABG

• 1-year incidence of unplanned revascularization

  Within 1 year post-CABG

Study Arms (2)

CCTA-Based CABG

EXPERIMENTAL

Procedure: CCTA-based CABG

CAG-Based CABG

ACTIVE COMPARATOR

Procedure: CAG-based CABG

Interventions

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.

CCTA-Based CABG

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.

CAG-Based CABG

Eligibility Criteria

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

You may qualify if:

• Referred to CABG treatment

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yunpeng Zhu, MD

CONTACT

0086-02164370045; zyp12220@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director of Clinical Research, Department of Cardiovascular Surgery

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 17, 2026
• Study Start: August 17, 2026
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)