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

Seoul St. Mary's Hospital

Status: Unknown

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

Treatments: Procedure: Percutaneous coronary intervention; Drug: Dual-antiplatelet therapy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02806102

XC15RSMI0089K

Details and patient eligibility

About

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

Full 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

Enrollment: 13,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

13,000 participants in 2 patient groups

High-risk

Description:

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

Treatment:

Procedure: Percutaneous coronary intervention

Drug: Dual-antiplatelet therapy

Drug: Dual-antiplatelet therapy

Procedure: Percutaneous coronary intervention

Low-risk

Description:

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

Treatment:

Procedure: Percutaneous coronary intervention

Drug: Dual-antiplatelet therapy

Drug: Dual-antiplatelet therapy

Procedure: Percutaneous coronary intervention