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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02806102
• Other study ID #: XC15RSMI0089K
• Status: Recruiting
• Phase: N/A
• First received: May 31, 2016
• Last updated: July 3, 2016
• Start date: January 2004
• Est. completion date: February 2018

Study information

• Verified date: July 2016
• Source: Seoul St. Mary's Hospital
• Contact: Kiyuk Chang, MD, PhD
• Phone: 82-2-2258-1139
• Email: kiyuk[@]catholic.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13000
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Percutaneous coronary intervention
Percutaneous coronary intervention

Drug:
• Dual-antiplatelet therapy
Dual AntiPlatelet Therapy

Procedure:
• Percutaneous coronary intervention
Percutaneous coronary intervention

Drug:
• Dual-antiplatelet therapy
Dual AntiPlatelet Therapy

Locations

Country	Name	City	State
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul St. Mary's Hospital	AstraZeneca, Chonnam National University, The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cumulative incidence of cardiovascular events beyond first year after percutaneous coronary intervention	Cardiac death, nonfatal myocardial infarction, or nonfatal stroke	From 1 year up to 5 years after percutaneous coronary intervention	No
Primary	Cumulative incidence of cardiovascular events	Cardiac death, nonfatal myocardial infarction, or nonfatal stroke	5 years	No
Secondary	Cumulative incidence of all-cause death		5 years	No
Secondary	Cumulative incidence of cardiac death		5 years	No
Secondary	Cumulative incidence of nonfatal myocardial infarction		5 years	No
Secondary	Cumulative incidence of nonfatal stroke		5 years	No
Secondary	Cumulative incidence of target lesion revascularization		5 years	No
Secondary	Cumulative incidence of target vessel revascularization		5 years	No
Secondary	Cumulative incidence of non-target vessel revascularization		5 years	No
Secondary	Cumulative incidence of definite/Probable stent thrombosis		5 years	No
Secondary	Cumulative incidence of hospitalization for heart failure		5 years	No
Secondary	Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5		5 years	No
Secondary	Bleeding defined as the thrombolysis In Myocardial Infarction major/minor		5 years	No
Secondary	Cumulative incidence of major adverse cardiac and cerebrovascular events	All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization	5 years	No