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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02806102
Enrollment
13000
Registered
2016-06-20
Start date
2004-01-31
Completion date
2018-02-28
Last updated
2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

PROCEDUREPercutaneous coronary intervention

Percutaneous coronary intervention

Dual AntiPlatelet Therapy

Sponsors

The Catholic University of Korea
CollaboratorOTHER
Chonnam National University
CollaboratorOTHER
AstraZeneca
CollaboratorINDUSTRY
Seoul St. Mary's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative incidence of cardiovascular events5 yearsCardiac death, nonfatal myocardial infarction, or nonfatal stroke

Secondary

MeasureTime frameDescription
Cumulative incidence of definite/Probable stent thrombosis5 years
Cumulative incidence of hospitalization for heart failure5 years
Cumulative incidence of nonfatal myocardial infarction5 years
Cumulative incidence of nonfatal stroke5 years
Cumulative incidence of target lesion revascularization5 years
Cumulative incidence of non-target vessel revascularization5 years
Cumulative incidence of all-cause death5 years
Cumulative incidence of cardiac death5 years
Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 55 years
Bleeding defined as the thrombolysis In Myocardial Infarction major/minor5 years
Cumulative incidence of major adverse cardiac and cerebrovascular events5 yearsAll-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization
Cumulative incidence of target vessel revascularization5 years

Other

MeasureTime frameDescription
Cumulative incidence of cardiovascular events beyond first year after percutaneous coronary interventionFrom 1 year up to 5 years after percutaneous coronary interventionCardiac death, nonfatal myocardial infarction, or nonfatal stroke

Countries

South Korea

Contacts

Primary ContactKiyuk Chang, MD, PhD
kiyuk@catholic.ac.kr82-2-2258-1139
Backup ContactYoungkeun Ahn, MD, PhD
cecilyk@chonnam.ac.kr82-62-220-6263

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026