Fractional Flow Reserve Derived From Computed Tomography Coronary Angiography in the Assessment and Management of Stable Chest Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,400
- 试验地点
- 2
- 主要终点
- Resource utilisation
研究概览
简要总结
To determine whether, in a population of patients presenting to the rapid access chest pain clinic (RACPC), routine FFRct (Fractional Flow Reserve Computed Tomography) as a default test is superior in terms of resource utilisation when compared to routine clinical pathway algorithms recommended by the National Institute for Health and Care Excellence (NICE)
详细描述
FORECAST is a randomised controlled trial comparing 1400 patients with new onset pain who are assigned to either routine assessment or FFRct assessment.
This trial aims to test the hypothesis that FFRct, used as the default screening tool for patients presenting with new onset stable chest pain, would be associated with (i) shorter time period between initial consultation and definitive management plan; (ii) better patient experience; (iii) lower overall use of resources.
The UK is well suited to test this hypothesis because of its well established system of Rapid Access Chest Pain Clinics (RACPC). The majority of patients presenting with stable chest pain (CP) that is of suspected cardiac origin are referred to such clinics, with a mandated access time within 2 weeks. The majority of such clinics work to the algorithm recommended in the NICE guidelines for Chest Pain of Recent Onset (March 2010). Within this guideline, patients are stratified according to their risk profile and pre-test likelihood of coronary artery disease (CAD) to outcomes that include discharge, stress test, CTCA (computed tomography coronary angiography), CT (computed tomography) coronary calcium score and invasive coronary angiogram.
Given the relative streamlining of this initial assessment of such patients throughout the country, it facilitates a comparison of strategies in FORECAST.
Once eligibility for the trial is confirmed and informed consent received, patients will be enrolled in the study and randomised to a treatment group (1:1 ratio)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Aged over 18
- •Primary symptom of chest pain
- •No contraindication to CTA
- •Willing and able to provide written informed consent
排除标准
- •Atrial fibrillation of new onset or when rate control has been difficult
- •Known bigemini/trigeminy
- •Prior CABG surgery
- •Allergic to contrast
- •Advanced renal impairment
- •Significant valve disease (severe aortic stenosis or regurgitation; severe mitral regurgitation)
- •Life expectancy <12 months
- •Inclusion in another trial without prior agreement with CI
结局指标
主要结局
Resource utilisation
时间窗: 9 months
To determine whether, in a population of patients presenting to RACPC, routine FFRct as a default test is superior, in terms of resource utilisation, when compared to routine clinical pathway algorithms recommended by NICE.
次要结局
- MACE(9 months)
- Quality of Life(9 months)