A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.
试验速览
- 阶段
- 不适用
- 入组人数
- 1,100
- 试验地点
- 34
- 主要终点
- Primary Economic Outcome Measure
研究概览
简要总结
A randomised controlled trial to compare two strategies for the investigation of coronary artery disease at the time of angiography. Patients will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm).
详细描述
The study will recruit patients undergoing angiography for the investigation of stable angina or for the assessment of a recent, but stabilised, non-ST elevation acute coronary syndrome event. Eligible patients who provide written informed consent will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm). The study pragmatic design allows investigators to conduct all diagnostic and therapeutic management in accordance with prevailing best practice patterns. Study outcome measures will examine resource utilisation, patient reported quality of life and clinical events at 1 year.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Conventional angiography
Routine angiography will be performed according to local best practice
Routine Measurement of FFR
Additional investigation with the measurement of FFR in all major vessels
干预措施: Routine Measurement of FFR (Device)
结局指标
主要结局
Primary Economic Outcome Measure
时间窗: One year
Resource utilisation as determined by hospital care costs at one year; All hospital admissions will be tracked using national hospital episode statistics; the cost of each episode will be derived from a cost model using standard UK tariffs. This analysis will compare the mean (or median) of the total hospital costs recorded for each patient over the 12 month follow-up period.
Primary Quality of Life Outcome Measure
时间窗: One year
Patient reported quality of life at one year using the EQ-5D health questionnaire.
次要结局
- Total hospital days(One year)
- All-cause mortality(One year)
- Number of hospitalisation events(One year)
- Angina symptoms(One year)
- Hospitalisation events(One year)
- Management strategy information(Reported once: Single declaration at index procedure after randomisation)