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

NCT ID: NCT02806102

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

13000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2018-02-28

Brief Summary

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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

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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

Conditions

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Acute Myocardial Infarction Percutaneous Coronary Intervention Major Adverse Cardiovascular Events Bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Dual-antiplatelet therapy

Intervention Type DRUG

Dual AntiPlatelet Therapy

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

Percutaneous coronary intervention

Intervention Type PROCEDURE

Percutaneous coronary intervention

Dual-antiplatelet therapy

Intervention Type DRUG

Dual AntiPlatelet Therapy

Interventions

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Percutaneous coronary intervention

Percutaneous coronary intervention

Intervention Type PROCEDURE

Dual-antiplatelet therapy

Dual AntiPlatelet Therapy

Intervention Type DRUG

Percutaneous coronary intervention

Percutaneous coronary intervention

Intervention Type PROCEDURE

Dual-antiplatelet therapy

Dual AntiPlatelet Therapy

Intervention Type DRUG

Other Intervention Names

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PCI DAPT PCI DAPT

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role collaborator

Chonnam National University

OTHER

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kiyuk Chang

Chief of the Division of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kiyuk Chang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Youngkeun Ahn, MD, PhD

Role: STUDY_DIRECTOR

Chonnam National University Hospital

Locations

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Chonnam National University Hospital

Gwangju, , South Korea

Site Status RECRUITING

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Kiyuk Chang, MD, PhD

Role: CONTACT

82-2-2258-1139

Youngkeun Ahn, MD, PhD

Role: CONTACT

82-62-220-6263

Facility Contacts

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Youngkeun Ahn, MD, PhD

Role: primary

82-62-220-6263

Kiyuk Chang, MD, PhD

Role: primary

82-2-2258-1139

References

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Kim KA, Kim SH, Lee KY, Yoon AH, Hwang BH, Choo EH, Kim JJ, Choi IJ, Kim CJ, Lim S, Park MW, Yoo KD, Jeon DS, Ahn Y, Jeong MH, Chang K. Predictors and Long-Term Clinical Impact of Heart Failure With Improved Ejection Fraction After Acute Myocardial Infarction. J Am Heart Assoc. 2024 Aug 20;13(16):e034920. doi: 10.1161/JAHA.124.034920. Epub 2024 Aug 19.

Reference Type DERIVED
PMID: 39158557 (View on PubMed)

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. Comparative Effectiveness of Long-Term Maintenance Beta-Blocker Therapy After Acute Myocardial Infarction in Stable, Optimally Treated Patients Undergoing Percutaneous Coronary Intervention. J Am Heart Assoc. 2023 Aug;12(15):e028976. doi: 10.1161/JAHA.122.028976. Epub 2023 Jul 26.

Reference Type DERIVED
PMID: 37493020 (View on PubMed)

Kim HY, Mok J, Kim JY, Jeon D, Her SH, Park MW, Kim DB, Park CS, Lee JM, Chang K, Jung WS, Ahn Y. Effect of Angiotensin Receptor Blocker Dose in Myocardial Infarction With Preserved Left Ventricular Systolic Function. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):52-60. doi: 10.1097/FJC.0000000000001427.

Reference Type DERIVED
PMID: 37019077 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36346059 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36000434 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34737035 (View on PubMed)

Other Identifiers

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XC15RSMI0089K

Identifier Type: -

Identifier Source: org_study_id

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