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

April 16, 2015 updated by: Kiyuk Chang

CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction Registry (COREA-AMI)

The purpose of this registry is to evaluate long-term clinical events in patients with acute myocardial infarction who were treated with percutaneous coronary intervention.

Although numerous articles have been published by using nationwide Korean myocardial infarction registries, such as the Korea Acute Myocardial Infarction Registry (KAMIR), limitation of previous registries is that these have little data beyond the first year of MI. Therefore, current registry was designed to assess long-term clinical events in patients with acute myocardial infarction.

Because most of myocardial infarction patients were treated by revascularization in real world of Korea, this registry limits the inclusion criteria to patients who were treated with percutaneous coronary intervention to reduce the bias.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

    8 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, such as such as the Korea Acute Myocardial Infarction Registry (KAMIR) (http://www.kamir.or.kr/).

All consecutive acute myocardial infarction patients had been enrolled in each registries prospectively.

Using these previous data, current registry update new clinical and angiographic variables and assess long-term clinical follow-up data retrospectively.

Study Type

Observational

Enrollment (Actual)

4748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute myocardial infarction who were treated with percutaneous coronary intervention

Description

Inclusion Criteria:

  • Acute myocardial infarction who were treated with percutaneous coronary intervention

Exclusion Criteria:

  • Acute myocardial infarction who were managed by conservative strategy
  • Acute myocardial infarction who were not treated with percutaneous coronary intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ST-segment elevation AMI
ST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention
Device: Percutaneous coronary intervention
Percutaneous coronary intervention
Non-ST-segment elevation AMI
Non-ST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention
Device: Percutaneous coronary intervention
Percutaneous coronary intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Major adverse cardiac and cerebrovascular events
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Cardiac death
Time Frame: 5 years
5 years
All-cause death
Time Frame: 5 years
5 years
Nonfatal myocardial infarction
Time Frame: 5 years
5 years
Nonfatal stroke
Time Frame: 5 years
5 years
Target lesion revascularization
Time Frame: 5 years
5 years
Target vessel revascularization
Time Frame: 5 years
5 years
Non-target vessel revascularization
Time Frame: 5 years
5 years
Definite/Probable stent thrombosis
Time Frame: 5 years
5 years
Hospitalization for heart failure
Time Frame: 5 years
5 years
Bleeding defined as the Bleeding Academic Research Consortium (BARC) definitions type 2, 3, and 5
Time Frame: 5 years
5 years
Bleeding defined as the thrombolysis In Myocardial Infarction (TIMI) major/minor
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kiyuk Chang

Collaborators

The Catholic University of Korea
Chonnam National University

Investigators

  • Principal Investigator: Ki-Bae Seung, MD, PhD, Seoul St. Mary's Hospital
  • Principal Investigator: Myung Ho Jeong, MD, PhD, Chonnam National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

March 5, 2015

First Submitted That Met QC Criteria

March 10, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 20, 2015

Last Update Submitted That Met QC Criteria

April 16, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC13RIMI0060k

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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