Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).
详细描述
About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Subject has coronary angiography confirmed triple-vessel disease.
- •Subject is ≥ 18 years of age at the time of inclusion.
- •Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status).
排除标准
- •Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
- •Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
- •Subjects with no way contact by telephone for follow-up.
结局指标
主要结局
All-cause mortality
时间窗: Through study completion, an average of 5 year
The mortality due to any cause
次要结局
- Myocardial infarction(Through study completion, an average of 5 year)
- Major adverse cardiac and cerebrovascular event(Through study completion, an average of 5 year)
- Stroke(Through study completion, an average of 5 year)
- Repeat revascularization(Through study completion, an average of 5 year)
研究者
Lei Song
MD
Chinese Academy of Medical Sciences, Fuwai Hospital