CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
- Conditions
- Acute Myocardial InfarctionPercutaneous Coronary InterventionMajor Adverse Cardiovascular EventsBleeding
- Interventions
- Procedure: Percutaneous coronary interventionDrug: Dual-antiplatelet therapy
- Registration Number
- NCT02806102
- Lead Sponsor
- Seoul St. Mary's Hospital
- Brief Summary
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
- Detailed Description
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.
Cardiovascular center with high-volume percutaneous coronary intervention of following hospitals were participated.
* Seoul St. Mary's Hospital, Seoul, South Korea
* Yeoido St. Mary's Hospital, Seoul, South Korea
* Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea
* St. Paul Hospital, Seoul, South Korea
* Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea
* Incheon St. Mary's Hospital, Incheon, South Korea
* St. Vincent Hospital, Gyeonggi-do, South Korea
* Deajon St. Mary's Hospital, Daejeon, South Korea
* Cheonnam University Hospital, Gwangju, South Korea
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 13000
- Acute myocardial infarction who were treated with percutaneous coronary intervention using stents
- Acute myocardial infarction who were treated with only balloon angioplasty
- Acute myocardial infarction who were managed by conservative strategy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description High-risk Percutaneous coronary intervention 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 High-risk Dual-antiplatelet therapy 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 Low-risk Percutaneous coronary intervention 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 Low-risk Dual-antiplatelet therapy 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
- Primary Outcome Measures
Name Time Method Cumulative incidence of cardiovascular events 5 years Cardiac death, nonfatal myocardial infarction, or nonfatal stroke
- Secondary Outcome Measures
Name Time Method Cumulative incidence of target vessel revascularization 5 years Cumulative incidence of non-target vessel revascularization 5 years Cumulative incidence of target lesion 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 nonfatal stroke 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 All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization
Trial Locations
- Locations (2)
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
🇰🇷Seoul, Korea, Republic of