International Patient-level Pooled Analysis of Comprehensive Physiologic Assessment: Collaborating Project of Korea, Japan, and Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,397
- 试验地点
- 4
- 主要终点
- Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
研究概览
简要总结
The current study evaluated prognostic implication of comprehensive physiologic assessment using fractional flow reserve, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR).
详细描述
The patient-level data was gathered from 3 nations (Korea, Japan, Spain). The total 1397 patients (1694 vessels) data was collected from 5 university hospitals in Korea (Seoul National University Hospital, Samsung Medical Centre, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Centre, and Ulsan University Hospital, Korea) and Tsuchiura Kyodo General Hospital, Ibaraki, Japan, and Hospital Clinico San Carlos, Madrid, Spain.
Standardized form of data collection sheet was used and all study adopted standardized definition of patient's baseline characteristics, clinical outcomes, and physiologic data. In case of acute coronary syndrome (unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction), only non-culprit vessel was included in the data.
Primary outcome is patient- and vessel-oriented composite outcome at 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 接受健康志愿者
- 否
入选标准
- •patients who underwent clinically indicated invasive coronary angiography and measurements of FFR, CFR, and IMR for at least 1 coronary artery
排除标准
- •Patients with hemodynamic instability
- •left ventricular dysfunction
- •culprit vessel of acute coronary syndrome
结局指标
主要结局
Cumulative incidence of a composite of any death, any myocardial infarction, or any ischemia-driven revascularization
时间窗: 5 year
Patient-oriented composite outcome
Cumulative incidence of a composite of cardiac death, target-vessel related myocardial infarction, or target-vessel revascularization
时间窗: 5 year
Vessel-oriented composite outcome
次要结局
- Cumulative incidence of cardiac death(5 year)
- Cumulative incidence of any death(5 year)
- Cumulative incidence of myocardial infarction(5 year)
- Cumulative incidence of ischemia-driven revascularization(5 year)
研究者
Bon-Kwon Koo
Professor
Seoul National University Hospital