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A large number of patients with symptomatic ischaemic heart disease undergo coronary artery bypass grafting (CABG) to alleviate their symptoms and improve prognosis. Given the progressive nature of coronary disease, bypass grafts can narrow or block over time, leading to chest pain and the need for further invasive coronary angiography. Invasive coronary procedures in patients with bypass grafts can be more complicated due to the variation in bypass graft ostia. This can lead to longer procedure times, with higher doses of contrast and radiation and more discomfort for the patient. The aim of this study is to see if the use of computed tomography cardiac angiography (CTCA) in patients with previous bypass grafts prior to invasive coronary angiography will help make their procedure safer and quicker.
The BYPASS-CTCA trial is a single-centre, randomised controlled trial, which plans to recruit 688 patients who have had previous bypass grafts and require invasive coronary angiography over a period of 30 months.
Patients will be randomised to receive either computed tomography cardiac angiography (CTCA) prior to their invasive coronary angiogram, or invasive coronary angiography alone.
The primary endpoints will be the incidence of contrast induced nephropathy, the duration of the invasive coronary angiographic procedure and patient satisfaction. A number of secondary endpoints will also be looked at.
Findings from BYPASS-CTCA will potentially demonstrate that a CTCA prior to invasive coronary angiography in this cohort of patients reduces the incidence of contrast-induced kidney injury, the length of procedure and improves patients satisfaction. The results of this trial may influence future clinical practice guidelines in coronary artery bypass graft patients undergoing invasive coronary procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTCA + ICA | Active Comparator | Computed Tomography Cardiac Angiography (CTCA) performed prior to invasive coronary angiogram (ICA). |
|
| ICA only | No Intervention | Invasive coronary angiogram (ICA) performed only. |
| 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 |
|---|---|---|
| Procedural duration | Length of invasive coronary angiogram | Interval between administration of local anaesthesia for obtaining vascular access and removal of the last catheter |
| Incidence of Contrast Induced Nephropathy | Defined by Kidney Disease: Improving Global outcomes (KDIGO) criteria | 48-72hours |
| Patient satisfaction | Patient satisfaction measured by validated questionnaire | 4-6hours |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast amount | Contrast amount (mls) administered during invasive coronary angiogram | From time of arterial sheath insertion to removal of arterial catheters |
| Radiation exposure | Radiation exposure (mSv) during invasive coronary angiogram |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Jones, MRCP, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39584261 | Derived | Kelham M, Beirne AM, Rathod KS, Andiapen M, Wynne L, Learoyd AE, Forooghi N, Ramaseshan R, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA. CTCA Prior to Invasive Coronary Angiography in Patients With Previous Bypass Surgery: Patient-Related Outcomes, Imaging Resource Utilization, and Cardiac Events at 3 Years From the BYPASS-CTCA Trial. Circ Cardiovasc Interv. 2024 Dec;17(12):e014142. doi: 10.1161/CIRCINTERVENTIONS.124.014142. Epub 2024 Nov 25. | |
| 38462389 |
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Trial protocol to be published
Late 2018
Freely available via journal
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 15, 2023 | |
| Reset | May 8, 2024 | |
| Release | Apr 28, 2025 |
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| From time of arterial sheath insertion to removal of arterial catheters |
| Angiography related complications | Angiography related complications (coronary or aortic dissection, stroke, bleeding, vascular access complications) | 4-6hours |
| Radial access rate | Radial access rates during invasive coronary angiogram | From time of randomisation to end of invasive coronary angiogram procedure |
| Catheters used | Number of catheters used during invasive coronary angiogram | From time of arterial sheath insertion to removal of arterial catheters |
| Computed Tomography Cardiac Angiography accuracy | Accuracy of the Computed Tomography Cardiac Angiography scan for detecting graft patency | From time of randomisation to end of invasive coronary angiogram procedure |
| Number of grafts not identified | Number of grafts not identified during invasive coronary angiogram | From time of arterial sheath insertion to removal of arterial catheters |
| Cost effectiveness of computed tomography cardiac angiography | Incremental Cost Effectiveness Ratio (ICER) | 12 months |
| Derived |
| Kelham M, Beirne AM, Rathod KS, Andiapen M, Wynne L, Ramaseshan R, Learoyd AE, Forooghi N, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA; BYPASS-CTCA Trial Investigators. The effect of CTCA guided selective invasive graft assessment on coronary angiographic parameters and outcomes: Insights from the BYPASS-CTCA trial. J Cardiovasc Comput Tomogr. 2024 May-Jun;18(3):291-296. doi: 10.1016/j.jcct.2024.03.004. Epub 2024 Mar 11. |
| 37772419 | Derived | Jones DA, Beirne AM, Kelham M, Rathod KS, Andiapen M, Wynne L, Godec T, Forooghi N, Ramaseshan R, Moon JC, Davies C, Bourantas CV, Baumbach A, Manisty C, Wragg A, Ahluwalia A, Pugliese F, Mathur A; BYPASS-CTCA Trial Committees and Investigators. Computed Tomography Cardiac Angiography Before Invasive Coronary Angiography in Patients With Previous Bypass Surgery: The BYPASS-CTCA Trial. Circulation. 2023 Oct 31;148(18):1371-1380. doi: 10.1161/CIRCULATIONAHA.123.064465. Epub 2023 Sep 29. |
| 34733947 | Derived | Beirne AM, Rathod KS, Castle E, Andiapen M, Richards A, Bellin A, Hammond V, Godec T, Moon JC, Davies C, Bourantas CV, Wragg A, Ahluwalia A, Pugliese F, Mathur A, Jones DA. The BYPASS-CTCA Study: the value of Computed Tomography Cardiac Angiography (CTCA) in improving patient-related outcomes in patients with previous bypass operation undergoing invasive coronary angiography: Study Protocol of a Randomised Controlled Trial. Ann Transl Med. 2021 Sep;9(17):1395. doi: 10.21037/atm-21-1455. |
| Reset | May 12, 2025 |
| Release | Jun 17, 2025 |
| Reset | Jul 3, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 15, 2023 | May 8, 2024 | |||
| Apr 28, 2025 | May 12, 2025 | |||
| Jun 17, 2025 | Jul 3, 2025 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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