Long-term Major Cardiovascular EventsCOREA-AMINCT02385682
CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Acute Myocardial Infarction
An observational study of Long-term Major Cardiovascular Events and Myocardial Infarction, run by Kiyuk Chang.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Long-term Major Cardiovascular Events, Myocardial Infarction, Percutaneous Coronary Intervention
- What is being tested?
- Percutaneous coronary intervention
- Type of treatment
- Medical device
- How many people
- 4,748 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 2014
- 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
Who cannot join
- Acute myocardial infarction who were managed by conservative strategy
- Acute myocardial infarction who were not treated with percutaneous coronary intervention
About this study
Official title: CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction Registry (COREA-AMI)
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.
Read the detailed 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.
- Conditions
- Long-term Major Cardiovascular Events, Myocardial Infarction, Percutaneous Coronary Intervention
- Being tested
- Percutaneous coronary intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous coronary interventionDevice
Percutaneous coronary intervention
Percutaneous coronary interventionDevice
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| ST-segment elevation AMI | ST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention Receives: Device: Percutaneous coronary intervention | |
| Non-ST-segment elevation AMI | Non-ST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention Receives: Device: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events
Measured: 5 years
Secondary outcomes (11)
All-cause death
Measured: 5 years
Cardiac death
Measured: 5 years
Nonfatal myocardial infarction
Measured: 5 years
Nonfatal stroke
Measured: 5 years
Target lesion revascularization
Measured: 5 years
Target vessel revascularization
Measured: 5 years
Non-target vessel revascularization
Measured: 5 years
Definite/Probable stent thrombosis
Measured: 5 years
Hospitalization for heart failure
Measured: 5 years
Bleeding defined as the Bleeding Academic Research Consortium (BARC) definitions type 2, 3, and 5
Measured: 5 years
Bleeding defined as the thrombolysis In Myocardial Infarction (TIMI) major/minor
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startJan 2004
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Long-term Major Cardiovascular EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 4,748 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kiyuk Chang
- Sponsor type
- University, hospital or other
- Collaborators
- The Catholic University of Korea, Chonnam National University
- Responsible party
- Sponsor-investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Ki-Bae Seung, MD, PhD, Principal investigator, Seoul St. Mary's HospitalMyung Ho Jeong, MD, PhD, Principal investigator, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385682
- Sponsor's protocol ID
- XC13RIMI0060k
- Acronym
- COREA-AMI
- Status last verified
- Apr 2015
- First submitted
- 5 Mar 2015
- Last updated
- 20 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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 36346059Lim S, Choo EH, Choi IJ, Ihm SH, Kim HY, Ahn Y, Chang K, Jeong MH, Seung KB. Angiotensin Receptor Blockers as an Alternative to Angiotensin-Converting Enzyme Inhibitors in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention. J Korean Med Sci. 2019 Nov 25;34(45):e289. doi: 10.3346/jkms.2019.34.e289.
PubMed 31760711Kim MC, Ahn Y, Cho JY, Lee KH, Sim DS, Yoon NS, Yoon HJ, Kim KH, Hong YJ, Park HW, Kim JH, Jeong MH, Cho JG, Park JC, Chang K, Seung KB. Benefit of Early Statin Initiation within 48 Hours after Admission in Statin-Naive Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2019 May;49(5):419-433. doi: 10.4070/kcj.2018.0341. Epub 2019 Feb 12.
PubMed 30808084
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CardiOvascular Risk and idEntificAtion of Potential High-risk Population in Korean Patients With Acute Myocardial Infarction Registry (COREA-AMI)
- ClinicalTrials.gov ID
- NCT02385682
- Acronym / sponsor ID
- COREA-AMI / XC13RIMI0060k
- Conditions
- Long-term Major Cardiovascular Events, Myocardial Infarction, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,748 participants (actual)
- Lead sponsor
- Kiyuk ChangUniversity, hospital or other
- Collaborators
- The Catholic University of Korea, Chonnam National University
- Study start
- Jan 2004
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ST-segment elevation AMI | – | Device: Percutaneous coronary interventionST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention |
| Non-ST-segment elevation AMI | – | Device: Percutaneous coronary interventionNon-ST-segment elevation acute myocardial infarction teated with percutaneous coronary intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute myocardial infarction who were treated with percutaneous coronary intervention
Key inclusion criteria (1 listed)
- Acute myocardial infarction who were treated with percutaneous coronary intervention
Key exclusion criteria (2 listed)
- Acute myocardial infarction who were managed by conservative strategy
- Acute myocardial infarction who were not treated with percutaneous coronary intervention
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous coronary interventionPercutaneous coronary intervention | Device | Non-ST-segment elevation AMI |
| Percutaneous coronary interventionPercutaneous coronary intervention | Device | ST-segment elevation AMI |
Primary outcome
Major adverse cardiac and cerebrovascular events
Time frame: 5 years
11 secondary outcomes
All-cause death
Time frame: 5 years
Cardiac death
Time frame: 5 years
Nonfatal myocardial infarction
Time frame: 5 years
Nonfatal stroke
Time frame: 5 years
Target lesion revascularization
Time frame: 5 years
Target vessel revascularization
Time frame: 5 years
Non-target vessel revascularization
Time frame: 5 years
Definite/Probable stent thrombosis
Time frame: 5 years
Hospitalization for heart failure
Time frame: 5 years
Bleeding defined as the Bleeding Academic Research Consortium (BARC) definitions type 2, 3, and 5
Time frame: 5 years
Bleeding defined as the thrombolysis In Myocardial Infarction (TIMI) major/minor
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2015.
- Derived from this study: PubMed 36346059Ahn 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.
- Derived from this study: PubMed 31760711Lim S, Choo EH, Choi IJ, Ihm SH, Kim HY, Ahn Y, Chang K, Jeong MH, Seung KB. Angiotensin Receptor Blockers as an Alternative to Angiotensin-Converting Enzyme Inhibitors in Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention. J Korean Med Sci. 2019 Nov 25;34(45):e289. doi: 10.3346/jkms.2019.34.e289.
- Derived from this study: PubMed 30808084Kim MC, Ahn Y, Cho JY, Lee KH, Sim DS, Yoon NS, Yoon HJ, Kim KH, Hong YJ, Park HW, Kim JH, Jeong MH, Cho JG, Park JC, Chang K, Seung KB. Benefit of Early Statin Initiation within 48 Hours after Admission in Statin-Naive Patients with Acute Myocardial Infarction Undergoing Percutaneous Coronary Intervention. Korean Circ J. 2019 May;49(5):419-433. doi: 10.4070/kcj.2018.0341. Epub 2019 Feb 12.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki-Bae Seung, MD, PhD principal investigator
Seoul St. Mary's Hospital
Myung Ho Jeong, MD, PhD principal investigator
Chonnam National University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Long-term Major Cardiovascular Events and Myocardial Infarction, run by Kiyuk Chang.
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: finished, as of the sponsor's last update on 20 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular 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 NCT02385682, which also lists 3 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 20 Apr 2015.