CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

— COREA-AMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02385682
• Other study ID #: XC13RIMI0060k
• Status: Completed
• Phase: N/A
• First received: March 5, 2015
• Last updated: April 16, 2015
• Start date: January 2004
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4748
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• 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

Exclusion Criteria:

• Acute myocardial infarction who were managed by conservative strategy

• Acute myocardial infarction who were not treated with percutaneous coronary intervention

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infarction
• Long-term Major Cardiovascular Events
• Myocardial Infarction
• Percutaneous Coronary Intervention

Intervention

Device:
• Percutaneous coronary intervention
Percutaneous coronary intervention
• Percutaneous coronary intervention
Percutaneous coronary intervention

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kiyuk Chang	Chonnam National University, The Catholic University of Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events		5 years	No
Secondary	All-cause death		5 years	No
Secondary	Cardiac death		5 years	No
Secondary	Nonfatal myocardial infarction		5 years	No
Secondary	Nonfatal stroke		5 years	No
Secondary	Target lesion revascularization		5 years	No
Secondary	Target vessel revascularization		5 years	No
Secondary	Non-target vessel revascularization		5 years	No
Secondary	Definite/Probable stent thrombosis		5 years	No
Secondary	Hospitalization for heart failure		5 years	No
Secondary	Bleeding defined as the Bleeding Academic Research Consortium (BARC) definitions type 2, 3, and 5		5 years	No
Secondary	Bleeding defined as the thrombolysis In Myocardial Infarction (TIMI) major/minor		5 years	No