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Acute Myocardial InfarctionNCT02806102

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

An observational study of Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Seoul St. Mary's Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
Percutaneous coronary intervention and Dual-antiplatelet therapy
Type of treatment
Surgery or procedure
How many people
13,000 participants
Where
2 sitesSouth Korea
Study dates
Jan 2004to Feb 2018
How long will I take part?
5 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Acute myocardial infarction who were treated with percutaneous coronary intervention

Who may be able to join

  • Acute myocardial infarction who were treated with percutaneous coronary intervention using stents

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Kiyuk Chang, MD, PhD contact

82-2-2258-1139

kiyuk@catholic.ac.kr

Youngkeun Ahn, MD, PhD contact

82-62-220-6263

cecilyk@chonnam.ac.kr

South Korea2 sites, 2 recruiting
  • Chonnam National University Hospital

    Gwangju

    Youngkeun Ahn, MD, PhD, 82-62-220-6263, cecilyk@chonnam.ac.kr

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

    Seoul

    Kiyuk Chang, MD, PhD, 82-2-2258-1139, kiyuk@catholic.ac.kr

    Kiyuk Chang, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: 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

Read the 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
Being tested
Percutaneous coronary intervention, Dual-antiplatelet therapy
Medical subject headings
Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Percutaneous coronary interventionProcedure or surgery

    Also called PCI

    Percutaneous coronary intervention

  • Dual-antiplatelet therapyDrug

    Also called DAPT

    Dual AntiPlatelet Therapy

  • Percutaneous coronary interventionProcedure or surgery

    Also called PCI

    Percutaneous coronary intervention

  • Dual-antiplatelet therapyDrug

    Also called DAPT

    Dual AntiPlatelet Therapy

Study groups in NCT02806102
Study groupRoleWhat they receive
High-riskAcute 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
Receives: Procedure: Percutaneous coronary intervention; Drug: Dual-antiplatelet therapy
Low-riskAcute 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
Receives: Procedure: Percutaneous coronary intervention; Drug: Dual-antiplatelet therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative incidence of cardiovascular events

    Cardiac death, nonfatal myocardial infarction, or nonfatal stroke

    Measured: 5 years

Secondary outcomes (12)
  1. Cumulative incidence of all-cause death

    Measured: 5 years

  2. Cumulative incidence of cardiac death

    Measured: 5 years

  3. Cumulative incidence of nonfatal myocardial infarction

    Measured: 5 years

  4. Cumulative incidence of nonfatal stroke

    Measured: 5 years

  5. Cumulative incidence of target lesion revascularization

    Measured: 5 years

  6. Cumulative incidence of target vessel revascularization

    Measured: 5 years

  7. Cumulative incidence of non-target vessel revascularization

    Measured: 5 years

  8. Cumulative incidence of definite/Probable stent thrombosis

    Measured: 5 years

  9. Cumulative incidence of hospitalization for heart failure

    Measured: 5 years

  10. Cumulative incidence of bleeding defined as the Bleeding Academic Research Consortium definitions type 2, 3, and 5

    Measured: 5 years

  11. Bleeding defined as the thrombolysis In Myocardial Infarction major/minor

    Measured: 5 years

  12. Cumulative incidence of major adverse cardiac and cerebrovascular events

    All-cause death, nonfatal myocardial infarction, nonfatal stroke, or any revascularization

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2016 (estimated)
  2. Study startJan 2004
  3. Primary completionFeb 2017 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
13,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02806102
Sponsor's protocol ID
XC15RSMI0089K
Status last verified
Jul 2016
First submitted
31 May 2016
Last updated
6 Jul 2016
Results posted
No

Publications

  • Hyun S, Kim KA, Kim SH, Lee M, Lim S, Hwang BH, Choo EH, Kim JJ, Choi IJ, Kim CJ, Park MW, Chang K, Lee KY. Long-term Impact of Residual Inflammatory Risk in Acute Myocardial Infarction Patients Treated With Percutaneous Coronary Intervention Who Achieved Optimal Lipid Control. Korean Circ J. 2026 Aug 5. doi: 10.4070/kcj.2025.0469. Online ahead of print.

    PubMed 42773911
  • Kim SH, Lee W, Choo EH, Lee KY, Hwang BH, Choi IJ, Lee JM, Yoo KD, Park MW, Park CS, Kim HY, Kim MC, Ahn Y, Chang K. Long-term outcomes of premature acute myocardial infarction: impact of multivessel disease. Coron Artery Dis. 2026 Aug 1;37(5):377-384. doi: 10.1097/MCA.0000000000001613. Epub 2026 Jan 20.

    PubMed 41555573
  • Kim SH, Choo EH, Kang J, Lee JM, Yoo KD, Park MW, Park CS, Kim HY, Kim MC, Ahn Y, Chang K, Kim HS. The efficacy and safety of prasugrel in acute coronary syndrome: a propensity-matched Korean cohort study focused on age and weight of patients. BMC Cardiovasc Disord. 2025 Nov 26;25(1):888. doi: 10.1186/s12872-025-05263-w.

    PubMed 41299333
  • Kim S, Lee KY, Kim KA, Byeon J, Shin S, Hwang BH, Kim JJ, Choo EH, Kim CJ, Kyoung Sa Y, Park MW, Hyun S, Yoon AH, Ahn Y, Chang K. The role of serum uric acid in survival prediction in patients with acute myocardial infarction accompanied by heart failure with preserved ejection fraction. Front Cardiovasc Med. 2025 Nov 10;12:1622275. doi: 10.3389/fcvm.2025.1622275. eCollection 2025.

    PubMed 41293617
  • 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.

    PubMed 39158557
  • Lim Y, Kim MC, Ahn JH, Lee SH, Hyun DY, Cho KH, Sim DS, Hong YJ, Kim JH, Jeong MH, Choi IJ, Choo EH, Lim S, Hwang BH, Park MW, Kim CJ, Park CS, Kim HY, Chang K, Ahn Y. Optimal timing of percutaneous coronary intervention for non-ST elevated myocardial infarction with congestive heart failure. Cardiovasc Revasc Med. 2024 Oct;67:87-93. doi: 10.1016/j.carrev.2024.04.295. Epub 2024 Apr 25.

    PubMed 38679500
  • Kim KA, Lee JE, Choi IJ, Lee KY, Kim CJ, Park MW, Park CS, Kim HY, Yoo KD, Jeon DS, Jeong MH, Chang K. Effect of Renin-Angiotensin System Blockers in Acute Myocardial Infarction Patients with Acute Kidney Injury. Cardiorenal Med. 2024;14(1):178-190. doi: 10.1159/000538042. Epub 2024 Mar 12.

    PubMed 38471483
  • 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.

    PubMed 37493020
  • 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.

    PubMed 37019077
  • 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.

    PubMed 36346059
  • 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.

    PubMed 36000434
  • 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.

    PubMed 34737035

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction and Percutaneous Coronary Intervention, run by Seoul St. Mary's Hospital at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kiyuk Chang, MD, PhD (82-2-2258-1139, kiyuk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of cardiovascular events (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02806102, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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