Clinical trial NCT02806102: CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction II (COREA-AMI II)
Official title: Cardiovascular Risk and Identification of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction II (COREA-AMI II)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Percutaneous Coronary Intervention
Major Adverse Cardiovascular Events
Bleeding
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: The Catholic University of Korea
name: Chonnam National University
name: AstraZeneca
First posted: 2016-06-20
Enrollment: 13000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute myocardial infarction who were treated with 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

Eligibility criteria: 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

Primary outcomes:
measure: Cumulative incidence of cardiovascular events
timeFrame: 5 years
Secondary outcomes:
measure: Cumulative incidence of all-cause death
timeFrame: 5 years
measure: Cumulative incidence of cardiac death
timeFrame: 5 years
measure: Cumulative incidence of nonfatal myocardial infarction
timeFrame: 5 years
measure: Cumulative incidence of nonfatal stroke
timeFrame: 5 years
measure: Cumulative incidence of target lesion revascularization
timeFrame: 5 years
measure: Cumulative incidence of target vessel revascularization
timeFrame: 5 years
measure: Cumulative incidence of non-target vessel revascularization
timeFrame: 5 years
measure: Cumulative incidence of definite/Probable stent thrombosis
timeFrame: 5 years
measure: Cumulative incidence of hospitalization for heart failure
timeFrame: 5 years
measure: Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5
timeFrame: 5 years
measure: Bleeding defined as the thrombolysis In Myocardial Infarction major/minor
timeFrame: 5 years
measure: Cumulative incidence of major adverse cardiac and cerebrovascular events
timeFrame: 5 years
Other outcomes:
measure: Cumulative incidence of cardiovascular events beyond first year after percutaneous coronary intervention
timeFrame: From 1 year up to 5 years after percutaneous coronary intervention
Locations:
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kiyuk Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chonnam National University Hospital
name: Youngkeun Ahn, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Ahn Y, Lee D, Choo EH, Choi IJ, Lim S, Lee KY, Hwang BH, Park MW, Lee JM, Park CS, Kim HY, Yoo KD, Jeon DS, Chung WS, Kim MC, Jeong MH, Ahn Y, Chang K. Association Between Bleeding and New Cancer Detection and the Prognosis in Patients With Myocardial Infarction. J Am Heart Assoc. 2022 Nov 15;11(22):e026588. doi: 10.1161/JAHA.122.026588. Epub 2022 Nov 8.
citation: Cho KH, Kim MC, Choo EH, Choi IJ, Lee SN, Park MW, Park CS, Kim HY, Kim CJ, Sim DS, Kim JH, Hong YJ, Jeong MH, Chang K, Ahn Y. Impact of Low Baseline Low-Density Lipoprotein Cholesterol on Long-Term Postdischarge Cardiovascular Outcomes in Patients With Acute Myocardial Infarction. J Am Heart Assoc. 2022 Sep 6;11(17):e025958. doi: 10.1161/JAHA.122.025958. Epub 2022 Aug 24.
citation: Lee M, Lee K, Kim DW, Cho JS, Kim TS, Kwon J, Kim CJ, Park CS, Kim HY, Yoo KD, Jeon DS, Chang K, Kim MC, Jeong MH, Ahn Y, Park MW. Relationship of Serial High-Sensitivity C-Reactive Protein Changes to Long-term Clinical Outcomes in Stabilised Patients After Myocardial Infarction. Can J Cardiol. 2022 Jan;38(1):92-101. doi: 10.1016/j.cjca.2021.10.007. Epub 2021 Nov 2.