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

RecruitingNA

Sponsor: Ruijin Hospital

Conditions: Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Computed Tomography Angiography, Coronary Angiography (CAG)

Interventions: CCTA-based CABG, CAG-based CABG

Countries: China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (1)

Shanghai, China