Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,103
- 试验地点
- 2
- 主要终点
- Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
研究概览
简要总结
The study will be a prospective, pragmatic, randomized clinical trial of the comparative effectiveness of diagnostic evaluation strategies for stable CAD, to be performed in outpatient settings, including primary care and cardiology practices.
详细描述
Objective was to test a modified initial cCTA strategy (PS) designed to improve clinical efficiency vs usual testing (UT). Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy PS or UT. PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
结局指标
主要结局
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease
时间窗: 1 year
The centrally adjudicated (by Clinical Events Committee) primary end point was a composite of clinical efficiency as a gatekeeper to invasive testing (catheterization without obstructive CAD) and safety (death, non fatal myocardial infarction \[MI\]) at 1 year. Invasive cardiac catheterization without obstructive coronary artery disease defined as the absence of any ≥50% stenosis or hemodynamic indication of significance (no FFR ≤0.80 or iFR≤0.89) in any major epicardial vessel including side branches ≥2 mm in diameter, as determined by core-lab adjudicated quantitative coronary angiography (QCA) or if QCA not performed, by site report. A detailed description and information on the definitions of primary endpoint component definitions is provided in the current version of the study Protocol, Statistical Analysis Plan, and the published trial design article.
次要结局
- Number of Unplanned Hospitalizations (Including Admissions With Death or MI)(1 year)
- Number of Participants With Quality of Life (Angina Frequency) Assessment(1 year)
- Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)(1 year)
- Number of Participants With Preventive Medication Use(1 Year)
- Number of Catheterization and Revascularization Procedures(1 year)