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

July 3, 2016 updated by: Kiyuk Chang, Seoul St. Mary's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

13000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Gwangju, Korea, Republic of
        • Recruiting
        • Chonnam National University Hospital
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St. Mary's Hospital, The Catholic University of Korea

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 using stents

Exclusion Criteria:

  • Acute myocardial infarction who were treated with only balloon angioplasty
  • Acute myocardial infarction who were managed by conservative strategy

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High-risk

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
Percutaneous coronary intervention
Other Names:
  • PCI
Drug: Dual-antiplatelet therapy
Dual AntiPlatelet Therapy
Other Names:
  • DAPT
Low-risk
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
Percutaneous coronary intervention
Other Names:
  • PCI
Drug: Dual-antiplatelet therapy
Dual AntiPlatelet Therapy
Other Names:
  • DAPT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of cardiovascular events
Time Frame: 5 years
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
Time Frame: 5 years
5 years
Cumulative incidence of cardiac death
Time Frame: 5 years
5 years
Cumulative incidence of nonfatal myocardial infarction
Time Frame: 5 years
5 years
Cumulative incidence of nonfatal stroke
Time Frame: 5 years
5 years
Cumulative incidence of target lesion revascularization
Time Frame: 5 years
5 years
Cumulative incidence of target vessel revascularization
Time Frame: 5 years
5 years
Cumulative incidence of non-target vessel revascularization
Time Frame: 5 years
5 years
Cumulative incidence of definite/Probable stent thrombosis
Time Frame: 5 years
5 years
Cumulative incidence of hospitalization for heart failure
Time Frame: 5 years
5 years
Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5
Time Frame: 5 years
5 years
Bleeding defined as the thrombolysis In Myocardial Infarction major/minor
Time Frame: 5 years
5 years
Cumulative incidence of major adverse cardiac and cerebrovascular events
Time Frame: 5 years
All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of cardiovascular events beyond first year after percutaneous coronary intervention
Time Frame: From 1 year up to 5 years after percutaneous coronary intervention
Cardiac death, nonfatal myocardial infarction, or nonfatal stroke
From 1 year up to 5 years after percutaneous coronary intervention

Collaborators and Investigators

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

Sponsor

Seoul St. Mary's Hospital

Collaborators

AstraZeneca
The Catholic University of Korea
Chonnam National University

Investigators

  • Study Director: Youngkeun Ahn, 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 (ANTICIPATED)

February 1, 2017

Study Completion (ANTICIPATED)

February 1, 2018

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (ESTIMATE)

June 20, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 3, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XC15RSMI0089K

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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