Randomized Evaluation of Routine Follow-up Coronary Angiography After Percutaneous Coronary Intervention Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 2
- 主要终点
- a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
研究概览
简要总结
The purpose of this study is to evaluate the long term clinical impact of routine follow-up coronary angiography after percutaneous coronary intervention (PCI). The primary endpoint is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at 3-year after percutaneous coronary intervention.
详细描述
Routine follow-up coronary angiography after percutaneous coronary intervention has been performed to detect restenosis in a lot of PCI centers in Japan. On the other hand, previous studies reported that routine follow-up coronary angiography might lead to unnecessary reinterventions in asymptomatic patients. In this situation, the effect of routine follow-up coronary angiography on long-term clinical outcomes remains unknown. The purpose of this study is to evaluate the long-term clinical impact of routine follow-up coronary angiography after PCI compared with clinical follow-up alone. The primary endpoint of this study is a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure at three-year after percutaneous coronary intervention. The design of this study is almost all-comer design enrolling patients received PCI without any exclusion criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients received percutaneous coronary intervention
- •Patients older than 20 years old
- •Patients who will not scheduled any staged percutaneous coronary intervention
排除标准
- 未提供
结局指标
主要结局
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
时间窗: 4.8 years
a composite of death/myocardial infarction/stroke/emergency hospitalization for acute coronary syndrome/hospitalization for congestive heart failure
次要结局
- hospitalization for congestive heart failure(4.8 years)
- cardiac death(4.8 years)
- myocardial infarction(4.8 years)
- death(4.8 years)
- clinically-driven target-lesion revascularization(4.8 years)
- angina(4.8 years)
- stroke(4.8 years)
- composite of cardiac death, myocardial infarction or acute coronary syndrome(4.8 years)
- stent thrombosis(4.8 years)
- bleeding complications(4.8 years)
- any coronary revascularization(4.8 years)
- clinically-driven coronary revascularization(4.8 years)
- any target-lesion revascularization(4.8 years)
- coronary artery bypass grafting(4.8 years)
- renal function(4.8 years)
- emergency hospitalization for acute coronary syndrome(4.8 years)
- clinically-driven follow-up coronary angiography(4.8 years)
- follow-up coronary angiography(4.8 years)
研究者
Takeshi Morimoto
Professor
Kyoto University, Graduate School of Medicine