Coronary Heart Disease
Conditions
Keywords
Coronary Artery Bypass Graft, Angina, Coronary Artery Disease, CABG, percutaneous coronary intervention, coronary angiograms, Computerised Tomography Coronary Angiography, CTCA
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTCTCA
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
Sponsors
Queen Mary University of London
National Institute for Health Research, United Kingdom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Arm A: coronary angiography alone Arm B: CTCA scan with or without angiography
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged ≥18 * Previous coronary artery bypass grafting (CABG) * An indication for coronary angiography * Angina * Ischaemia on perfusion imaging * Acute coronary syndrome * Patients are able and willing to give their written informed consent
Exclusion criteria
* Subjects presenting with ST segment myocardial infarction within window for primary PCI * Patients considered unsuitable to participate by the research team (e.g. due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures) * Life expectancy less than 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite major adverse cardiovascular events (MACE): all-cause mortality, non-fatal stroke, non-fatal myocardial infarction, and cardiovascular hospitalisation | Up to 2.5 years post-randomisation (median follow-up: 18 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluoroscopy time during coronary angiography | During coronary angiography procedure | Unit of Measure: Minutes |
| Incidence of procedural complications during coronary angiography | During coronary angiography procedure | Unit of Measure: Number of participants with event |
| Radiation dose during coronary angiography | During coronary angiography procedure | Unit of Measure: Milligray (mGy) |
| Contrast dose administered during coronary angiography | During coronary angiography procedure | Unit of Measure: Milliliters (mL) |
| Procedural duration during coronary angiography | During coronary angiography procedure | Unit of Measure: Minutes Unit of Measure: Milliliters (mL) |
| Health-related quality of life (EQ-5D-5L) | Baseline, 6 months, 12 months, 18 months, and 24 months | Assessed using the EQ-5D-5L questionnaire at baseline and every 6 months during follow-up. |
| Cost-effectiveness and productivity loss | Baseline and every 6 months during follow-up | Evaluated using patient questionnaires capturing healthcare resource use and productivity loss at baseline and every 6 months. |
| Days alive and out of hospital | From randomisation until end of follow-up (up to 2.5 years) | Total number of days the participant is alive and not admitted to hospital during the follow-up period. Unit of Measure: Days |
| Length of hospital stay | From randomisation until end of follow-up (up to 2.5 years) | Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Days |
| Major Adverse Cardiovascular Events (MACE) - Individual components | From randomisation until end of follow-up (up to 2.5 years) | Cumulative duration of hospital admissions during the follow-up period Unit of Measure: Number of events |
| Composite two-point MACE (death and MI) | From randomisation until end of follow-up (up to 2.5 years) | Includes death and myocardial infarction as a simplified composite cardiovascular endpoint. |
| Major Adverse Cardiovascular Events (MACE) - Cumulative incidence | From randomisation until end of follow-up (up to 2.5 years) | Total number of MACE events per participant during the follow-up period. Unit of Measure: Number of events |
| Unplanned revascularisation | From randomisation until end of follow-up (up to 2.5 years) | Number of unplanned coronary revascularisation procedures performed during follow-up. Unit of Measure: Number of procedures |
| Cardiovascular imaging utilisation | From randomisation until end of follow-up (up to 2.5 years) | Number and type of cardiovascular imaging procedures performed during follow-up. Unit of Measure: Number of procedures |
Countries
United Kingdom
Contacts
CONTACTMervyn Andiapen
CONTACTMatthew Kelham, MBBS, MD
PRINCIPAL_INVESTIGATORDaniel Jones, MRCP, PhD
Queen Mary University of London
Outcome results
None listed