The goal of this clinical trial is to evaluate whether a coronary computed tomography angiography (CTCA)-guided strategy can reduce the risk of death, heart attack, stroke, and hospital admissions in patients experiencing angina or myocardial infarction following coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: * Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography? * Is CTCA a cost-effective and safer alternative that improves patient quality of life? Researchers will compare outcomes between patients receiving CTCA prior to angiography and those undergoing standard angiography alone to determine if CTCA improves clinical outcomes and procedural safety. Participants will: * Be randomly assigned to either CTCA-guided care or standard angiography * Undergo coronary imaging and follow-up assessments * Complete questionnaires on quality of life and healthcare resource use
Patients with prior coronary artery bypass graft (CABG) surgery frequently present with recurrent angina or acute coronary syndromes due to progressive native coronary artery disease or graft failure. Invasive coronary angiography remains the standard diagnostic approach but is technically challenging in this population due to variable graft anatomy, leading to prolonged procedure times, increased radiation exposure, higher contrast volumes, and elevated risk of procedural complications. Computed Tomography Coronary Angiography (CTCA) offers a non-invasive alternative with high diagnostic accuracy for graft patency and coronary anatomy. Prior observational data (e.g., BYPASS-CTCA study) suggest that CTCA performed prior to invasive angiography may improve procedural efficiency and safety. However, whether CTCA can guide clinical decision-making to avoid unnecessary angiography and improve long-term outcomes remains unproven. This multi centre, randomised controlled trial will enrol 1,000 patients with prior CABG presenting with angina or myocardial infarction. Participants will be randomised to either a CTCA-guided strategy or standard care involving direct invasive coronary angiography. In the CTCA arm, angiography may be deferred if CTCA findings support medical management. The primary outcome is the composite rate of major adverse cardiovascular events (MACE), including death, myocardial infarction, stroke, and hospitalisation for unstable angina. Secondary outcomes include procedural metrics, patient-reported quality of life, cost-effectiveness, and healthcare resource utilization. Clinical data will be collected through patient questionnaires, procedural records, and central registry downloads. The study incorporates patient and public involvement throughout its design and implementation. Results will be disseminated via peer-reviewed publications, public-facing reports, and digital platforms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
1,000
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
Composite major adverse cardiovascular events (MACE): all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation
Clinical events will be assessed from randomisation until the final patient completes 6 months of follow-up. The composite endpoint includes all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation. Based on a 2-year recruitment period, individual follow-up will range from 0.5 to 2.5 years, with an estimated median follow-up of 18 months.
Time frame: Up to 2.5 years post-randomisation (median follow-up: 18 months)
Fluoroscopy time during coronary angiography
Unit of Measure: Minutes
Time frame: During coronary angiography procedure
Incidence of procedural complications during coronary angiography
Unit of Measure: Number of participants with event
Time frame: During coronary angiography procedure
Radiation dose during coronary angiography
Unit of Measure: Milligray (mGy)
Time frame: During coronary angiography procedure
Contrast dose administered during coronary angiography
Unit of Measure: Milliliters (mL)
Time frame: During coronary angiography procedure
Procedural duration during coronary angiography
Unit of Measure: Minutes Unit of Measure: Milliliters (mL)
Time frame: During coronary angiography procedure
Health-related quality of life (EQ-5D-5L)
Assessed using the EQ-5D-5L questionnaire at baseline and every 6 months during follow-up.
Time frame: Baseline, 6 months, 12 months, 18 months, and 24 months
Cost-effectiveness and productivity loss
Evaluated using patient questionnaires capturing healthcare resource use and productivity loss at baseline and every 6 months.
Time frame: Baseline and every 6 months during follow-up
Days alive and out of hospital
Total number of days the participant is alive and not admitted to hospital during the follow-up period. Unit of Measure: Days
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Length of hospital stay
Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Days
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Major Adverse Cardiovascular Events (MACE) - Individual components
Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Number of events
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Composite two-point MACE (death and MI)
Includes death and myocardial infarction as a simplified composite cardiovascular endpoint.
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Major Adverse Cardiovascular Events (MACE) - Cumulative incidence
Total number of MACE events per participant during the follow-up period. Unit of Measure: Number of events
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Unplanned revascularisation
Number of unplanned coronary revascularisation procedures performed during follow-up. Unit of Measure: Number of procedures
Time frame: From randomisation until end of follow-up (up to 2.5 years)
Cardiovascular imaging utilisation
Number and type of cardiovascular imaging procedures performed during follow-up. Unit of Measure: Number of procedures
Time frame: From randomisation until end of follow-up (up to 2.5 years)
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