Cardiovascular Risk and Identification of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction II (COREA-AMI II)
试验速览
- 阶段
- 不适用
- 入组人数
- 13,000
- 试验地点
- 2
- 主要终点
- Cumulative incidence of cardiovascular events
研究概览
简要总结
This study is intended to provide contemporary data on the residual cardiovascular risk in all consecutive patients with acute myocardial infarction, especially in patients who survived stably within one-year after percutaneous coronary intervention.
In addition, this study will identify which baseline clinical, angiographic, or treatment factors are associated with residual cardiovascular risk and bleeding events
详细描述
COREA-AMI registry was conducted previously (NCT02385682) and enrolled consecutive all patient with acute myocardial infarction who were treated with percutaneous coronary intervention from Jan 2004 to Dec 2009.
COREA-AMI II registry extend the enrollment period to Aug 2014 and the follow-up period to Jun 2016.
All consecutive acute myocardial infarction patients had been enrolled prospectively in prior registries of each university hospitals. Eight hospitals of the Catholic University of Korea already have web-based coronary intervention registry (NCT01239914). And Cheonnam University Hospital is one of leading hospitals to design and manage the web-based previous Korean nationwide myocardial infarction registry, the Korea Acute Myocardial Infarction Registry (KAMIR) (http://www.kamir.or.kr/).
Using these previous data, the current registry update new clinical and angiographic variables and assess long-term clinical follow-up data retrospectively. All data were collected on web-based system after eliminating personal information. (http://www.ecrf.kr/coreaami/)
All data are going to be sealed with code by Clinical Research Coordinating Center of the Catholic University of Korea and to be managed and analyzed by independent statistics perssonels.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Acute myocardial infarction who were treated with percutaneous coronary intervention using stents
排除标准
- •Acute myocardial infarction who were treated with only balloon angioplasty
- •Acute myocardial infarction who were managed by conservative strategy
研究组 & 干预措施
High-risk
Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have at least one of the following risk factors:
- Age ≥ 65 years
- Diabetes mellitus requiring medication
- Documented history of a second prior presumed spontaneous MI (>1 year ago)
- Documented history of angiographic evidence of multivessel coronary artery disease
- Chronic, non-end stage renal dysfunction
干预措施: Percutaneous coronary intervention (Procedure)
High-risk
Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have at least one of the following risk factors:
- Age ≥ 65 years
- Diabetes mellitus requiring medication
- Documented history of a second prior presumed spontaneous MI (>1 year ago)
- Documented history of angiographic evidence of multivessel coronary artery disease
- Chronic, non-end stage renal dysfunction
干预措施: Dual-antiplatelet therapy (Drug)
Low-risk
Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have none of the pre-specified risk factors
干预措施: Percutaneous coronary intervention (Procedure)
Low-risk
Acute myocardial infarction treated with percutaneous coronary intervention and/or long-term use of dual-antiplatelet therapy and have none of the pre-specified risk factors
干预措施: Dual-antiplatelet therapy (Drug)
结局指标
主要结局
Cumulative incidence of cardiovascular events
时间窗: 5 years
Cardiac death, nonfatal myocardial infarction, or nonfatal stroke
次要结局
- Cumulative incidence of nonfatal stroke(5 years)
- Cumulative incidence of target lesion revascularization(5 years)
- Cumulative incidence of target vessel revascularization(5 years)
- Cumulative incidence of non-target vessel revascularization(5 years)
- Cumulative incidence of all-cause death(5 years)
- Cumulative incidence of cardiac death(5 years)
- Cumulative incidence of nonfatal myocardial infarction(5 years)
- Cumulative incidence of definite/Probable stent thrombosis(5 years)
- Cumulative incidence of hospitalization for heart failure(5 years)
- Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5(5 years)
- Bleeding defined as the thrombolysis In Myocardial Infarction major/minor(5 years)
- Cumulative incidence of major adverse cardiac and cerebrovascular events(5 years)
研究者
Kiyuk Chang
Chief of the Division of Cardiology
Seoul St. Mary's Hospital