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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
688
Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
Barts Health NHS Trust
London, United Kingdom
Procedural duration
Length of invasive coronary angiogram
Time frame: 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
Time frame: 48-72hours
Patient satisfaction
Patient satisfaction measured by validated questionnaire
Time frame: 4-6hours
Contrast amount
Contrast amount (mls) administered during invasive coronary angiogram
Time frame: From time of arterial sheath insertion to removal of arterial catheters
Radiation exposure
Radiation exposure (mSv) during invasive coronary angiogram
Time frame: 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)
Time frame: 4-6hours
Radial access rate
Radial access rates during invasive coronary angiogram
Time frame: From time of randomisation to end of invasive coronary angiogram procedure
Catheters used
Number of catheters used during invasive coronary angiogram
Time frame: 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
Time frame: 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
Time frame: From time of arterial sheath insertion to removal of arterial catheters
Cost effectiveness of computed tomography cardiac angiography
Incremental Cost Effectiveness Ratio (ICER)
Time frame: 12 months
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