A Randomised Controlled Trial Assessing the Value of Computed Tomography Cardiac Angiography in Improving Patient Satisfaction and Reducing Contrast Load, Procedural Duration and Complications in Patients Who Had Previous Bypass Operation Undergoing Invasive Coronary Angiography
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 688
- 试验地点
- 1
- 主要终点
- Procedural duration
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing invasive coronary angiogram +/- percutaneous coronary Intervention
- •Previous Coronary Artery Bypass Grafting (CABG)
- •Patients able and willing to give their written informed consent.
排除标准
- •Subjects presenting with ST elevation myocardial infarction, cardiogenic shock (systolic blood pressure <80 mmHg for >30 minutes, or requiring inotropes or emergency intra aortic balloon pump for hypotension treatment) or cardiopulmonary resuscitation.
- •Subjects with eGFR <20ml/min or on renal replacement therapy.
- •Current life-threatening condition other than vascular disease that may prevent a subject completing the study.
- •Clinical instability including cardiogenic shock, hypotension (low blood pressure-systolic blood pressure less than 90 mmHg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
- •Inability to tolerate beta-blockers, including those with chronic obstructive pulmonary disease or asthma, complete heart block, second-degree atrioventricular block
- •Known contrast dye allergy.
- •Pregnancy or unknown pregnancy status.
- •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).
- •Inability or refusal to provide informed consent.
- •Any inclusion criteria not met
结局指标
主要结局
Procedural duration
时间窗: Interval between administration of local anaesthesia for obtaining vascular access and removal of the last catheter
Length of invasive coronary angiogram
Incidence of Contrast Induced Nephropathy
时间窗: 48-72hours
Defined by Kidney Disease: Improving Global outcomes (KDIGO) criteria
Patient satisfaction
时间窗: 4-6hours
Patient satisfaction measured by validated questionnaire
次要结局
- Radiation exposure(From time of arterial sheath insertion to removal of arterial catheters)
- Radial access rate(From time of randomisation to end of invasive coronary angiogram procedure)
- Contrast amount(From time of arterial sheath insertion to removal of arterial catheters)
- Angiography related complications(4-6hours)
- Catheters used(From time of arterial sheath insertion to removal of arterial catheters)
- Computed Tomography Cardiac Angiography accuracy(From time of randomisation to end of invasive coronary angiogram procedure)
- Number of grafts not identified(From time of arterial sheath insertion to removal of arterial catheters)
- Cost effectiveness of computed tomography cardiac angiography(12 months)