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

Ruijin Hospital826 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

826

Conditions

Coronary Artery Disease Coronary Artery Bypass Grafting

Interventions

CCTA-based CABGPROCEDURE

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 CABGPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: Within 1 year post-CABG

Secondary Outcomes

1-year incidence of all-cause death

Time frame: Within 1 year post-CABG

1-year incidence of CV death

Time frame: within 1 year post-CABG

1-year incidence of MI

Time frame: Within 1 year post-CABG

1-year incidence of stroke

Time frame: Within 1 year post-CABG

1-year incidence of unplanned revascularization

Time frame: Within 1 year post-CABG

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

Time frame: Within 1 year post-CABG

30-day incidence of the operative mortality and morbidity

The operative mortality and morbidity was defined as a composite of all-cause death, myocardial infarction, stroke, unplanned revascularization, cardiac arrest, reoperation, prolonged ventilation, deep sternal wound infection, pacemaker implantation, major gastrointestinal bleeding, and new dialysis .

Time frame: Within 30 days post-CABG

7-day graft failure rate

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

Time frame: At 7 day post-CABG

1-year graft failure rate

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

Time frame: At 1 year post-CABG

Other serious adverse events (SAE)

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

Time frame: Within 1 year post-CABG

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts