Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS) (LOTUS)
2015年12月17日 更新者:Lei Song、Chinese Academy of Medical Sciences, Fuwai Hospital
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).
研究概览
详细说明
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.
研究类型
观察性的
注册 (预期的)
10000
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Beijing
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Beijing、Beijing、中国、100037
- 招聘中
- Fuwai Hospital
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接触:
- Lei Song, MD
- 邮箱:drsongfw@gmail.com
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接触:
- Lei Song, MD
- 邮箱:lsongqd@yahoo.com
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首席研究员:
- Lei Song, MD, PhD
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副研究员:
- Zhan Gao, MD
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副研究员:
- Xueyan Zhao, MD
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副研究员:
- Lei Song, MD
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副研究员:
- Yin Zhang, MM
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副研究员:
- Lin Jiang, MD
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副研究员:
- Xinxing Feng, MD
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Between April 2004 and April 2018 in Fuwai Hospital, Beijing, China, consecutive patients with angiography confirmed triple-vessel coronary disease.
描述
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Percutaneous coronary intervention
Patients with triple-vessel coronary artery disease underwent percutaneous coronary intervention.
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Coronary artery bypass graft
Patients with triple-vessel coronary artery disease underwent coronary artery bypass graft.
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Optimal medication therapy
Patients with triple-vessel coronary artery disease underwent optimal medication therapy only.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
All-cause mortality
大体时间:Through study completion, an average of 5 year
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The mortality due to any cause
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Through study completion, an average of 5 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Major adverse cardiac and cerebrovascular event
大体时间:Through study completion, an average of 5 year
|
The incidence rate of major adverse cardiac and cerebrovascular event (MACCE), which is a combination of all-cause death, myocardial infarction, stroke and repeat revascularization
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Through study completion, an average of 5 year
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Myocardial infarction
大体时间:Through study completion, an average of 5 year
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The Incidence rate of myocardial infarction, including ST elevation myocardial infarction and non-ST elevation myocardial infarction
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Through study completion, an average of 5 year
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Stroke
大体时间:Through study completion, an average of 5 year
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The incidence rate of stroke, including cerebral infarction and hemorrhage
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Through study completion, an average of 5 year
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Repeat revascularization
大体时间:Through study completion, an average of 5 year
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The incidence rate of repeat revascularization, including target vessel revascularization and non-target vessel revascularization
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Through study completion, an average of 5 year
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Lei Song, MD、Fuwai Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2004年4月1日
初级完成 (预期的)
2016年4月1日
研究完成 (预期的)
2018年12月1日
研究注册日期
首次提交
2015年12月14日
首先提交符合 QC 标准的
2015年12月15日
首次发布 (估计)
2015年12月17日
研究记录更新
最后更新发布 (估计)
2015年12月18日
上次提交的符合 QC 标准的更新
2015年12月17日
最后验证
2015年12月1日
更多信息
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