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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 coronary 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 coronary 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 angiography (ICA). |
|
| ICA only | No Intervention | Invasive coronary angiography (ICA) performed only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTCA | Procedure | Computed Tomography Coronary Angiography (CTCA) performed prior to invasive coronary angiography (ICA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Procedural duration | To measure the length of coronary angiographic procedure | timer started after the insertion of the arterial catheter and stopped when the catheters are removed |
| Incidence of Contrast Induced Nephropathy | Defined by Kidney Disease: Improving Global Outcomes (KDIGO) criteria | 48-72 hours |
| Patient Satisfaction | Patient satisfaction measured by validated questionnaire | 4-6 hours post angiogram +/- percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Contrast Amount | Contrast amount (mls) administered during invasive coronary angiography | During procedure |
| Radiation Exposure | Radiation exposure (mSv) during invasive coronary angiography |
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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 |
|---|---|---|---|---|---|---|
| Royal London Hospital | London | E1 1FR | United Kingdom | |||
| St Bartholomew's Hospital |
The trial protocol will be published
Mid-late 2018
Freely available via journal
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| During procedure |
| Angiography Related Complications | Angiography related complications (such as coronary or aortic dissection, stroke, bleeding, vascular access complication) | During procedure |
| Radial Access Rate | Radial access rates during invasive coronary angiography | During procedure |
| Catheters Used | Number of catheters used during invasive coronary angiography | During procedure |
| Computed Tomography Cardiac Angiography Accuracy | Accuracy of the computed tomography cardiac angiography scan for detecting graft patency | Computed Tomography Cardiac Angiography (CTCA) |
| Number of grafts not identified | Number of grafts not identified during invasive coronary angiography | During procedure |
| Cost effectiveness of computed tomography cardiac angiography | Cost effectiveness of the intervention (per quality-adjusted life years) measured over 12 months of follow-up | 12 months |
| London |
| United Kingdom |
| 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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