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| ID | Type | Description | Link |
|---|---|---|---|
| NIHR207209 | Other Grant/Funding Number | NIHR Research for Patient Benefit | |
| PR2300245 | Other Grant/Funding Number | Siemens Healthcare Limited |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICA only | No Intervention | Invasive coronary angiogram (ICA) performed only. | |
| CTCA with or without ICA | Active Comparator | Computed Tomography Cardiac Angiography (CTCA) with or without invasive coronary angiogram (ICA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTCA | Diagnostic Test | Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 2.5 years post-randomisation (median follow-up: 18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Fluoroscopy time during coronary angiography | Unit of Measure: Minutes | During coronary angiography procedure |
| Incidence of procedural complications during coronary angiography | Unit of Measure: Number of participants with event |
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Inclusion Criteria:
Aged ≥18
Previous coronary artery bypass grafting (CABG)
An indication for coronary angiography
Patients are able and willing to give their written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mervyn Andiapen | Contact | 0203 765 8707 | mervyn.andiapen@nhs.net | |
| Matthew Kelham, MBBS, MD | Contact | m.kelham@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Daniel Jones, MRCP, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Bartholomew's Hospital | Recruiting | London | United Kingdom |
Data sharing available from corresponding author upon reasonable request and with approval from trial steering committee.
2028
Freely available via journal
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D000787 | Angina Pectoris |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Arm A: coronary angiography alone Arm B: CTCA scan with or without angiography
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| During coronary angiography procedure |
| Radiation dose during coronary angiography | Unit of Measure: Milligray (mGy) | During coronary angiography procedure |
| Contrast dose administered during coronary angiography | Unit of Measure: Milliliters (mL) | During coronary angiography procedure |
| Procedural duration during coronary angiography | Unit of Measure: Minutes Unit of Measure: Milliliters (mL) | 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. | 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. | 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 | 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 | 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 | 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. | 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 | 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 | 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 | From randomisation until end of follow-up (up to 2.5 years) |
| D002637 |
| Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |