CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)

Study Overview
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Brief Summary
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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
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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

Official Title
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Cardiovascular Risk and Identification of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction II (COREA-AMI II)

Conditions
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Acute Myocardial Infarction, Percutaneous Coronary Intervention, Major Adverse Cardiovascular Events, Bleeding

Intervention / Treatment
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* Procedure: Percutaneous coronary intervention
* Drug: Dual-antiplatelet therapy
* Procedure: Percutaneous coronary intervention
* Drug: Dual-antiplatelet therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute myocardial infarction who were treated with percutaneous coronary intervention using stents Exclusion Criteria: Acute myocardial infarction who were treated with only balloon angioplasty Acute myocardial infarction who were managed by conservative strategy

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| High-risk<br>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 | Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>* Other names: PCI;Drug: Dual-antiplatelet therapy<br>* Dual AntiPlatelet Therapy<br>* Other names: DAPT;|
| Low-risk<br>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 | Procedure: Percutaneous coronary intervention<br>* Percutaneous coronary intervention<br>* Other names: PCI;Drug: Dual-antiplatelet therapy<br>* Dual AntiPlatelet Therapy<br>* Other names: DAPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative incidence of cardiovascular events | Cardiac death, nonfatal myocardial infarction, or nonfatal stroke | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 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 | All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization | 5 years |