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Coronary Artery DiseaseNCT03908463

KOMATE Registry: Korean Multicenter Angioplasty Team

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Yonsei University at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators will enroll the patients who underwent PCI and was based on real world clinical practice to collect the data regarding demographic, clinical, procedural information and clinical outcome using case report forms. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Percutaneous coronary intervention
Type of treatment
Medical device
How many people
20,000 participants
Where
1 siteSouth Korea
Study dates
5 Oct 2018to Apr 2039
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: The patients who undergo percutaneous coronary intervention group/Cohort Description: The patients who undergo percutaneous coronary intervention will be enrolled.

Who may be able to join

  • 1. Patients older than 19 years
  • 2. Patients who undergo percutaneous coronary intervention

Who cannot join

  • 1. Refuse to participate
  • 2. Pregnant women or women with potential childbearing

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site, 1 recruiting

  • Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea

    Seoul

    Byeong-Keuk Kim, PhD, 82-2-2228-8460, kimbk@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

The investigators will enroll the patients who underwent PCI and was based on real world clinical practice to collect the data regarding demographic, clinical, procedural information and clinical outcome using case report forms.

Being tested
Percutaneous coronary intervention
Medical subject headings
Coronary Artery Disease, Acute Coronary Syndrome, Myocardial Infarction

What participants receive

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

  • Percutaneous coronary interventionDevice

    All coronary intervention procedures will be performed according to current standard techniques.

Study groups in NCT03908463
Study groupRoleWhat they receive
The patients who undergo percutaneous coronary interventionThe patients who undergo percutaneous coronary intervention will be enrolled.
Receives: Device: Percutaneous coronary intervention

What is being measured

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

  1. Target lesion revascularization

    Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. Clinically indicated revascularization: A revascularization is considered clinically indicated if angiography at followup shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
    2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    3. Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve);
    4. A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

    Measured: Up to 20 years

  2. Target vessel revascularization

    Defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLRs should be classified prospectively as clinically indicated or not clinically indicated by the investigator prior to repeat angiography. Clinically indicated revascularization: A revascularization is considered clinically indicated if angiography at followup shows a percent diameter stenosis ≥ 50% and if one of the following occurs:

    1. A positive history of recurrent angina pectoris, presumably related to the target vessel;
    2. Objective signs of ischemia at rest (ECG changes) or during exercise test (or equivalent), presumably related to the target vessel;
    3. Abnormal results of any invasive functional diagnostic test (eg, Doppler flow velocity reserve, fractional flow reserve);
    4. A TLR or TVR with a diameter stenosis ≥ 70% even in the absence of the above-mentioned ischemic signs or symptoms.

    Measured: Up to 20 years

  3. Stent thrombosis

    Stent thrombosis is defined and discussed by the Academic Research Consortium

    Measured: Up to 20 years

  4. Myocardial infarction

    Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium

    Measured: Up to 20 years

  5. Death

    All death will be recorded and their reason also be recorded. Also, cardiac death is defined as death due to myocardial infarction, cardiac perforation, tamponade, arrhythmia or any cardiac cause.

    Measured: Up to 20 years

  6. Non-target vessel revascularization

    Any revascularization of target-vessel revascularization will be collected.

    Measured: Up to 20 years

  7. Cerebrovascular accident

    Sudden onset of vertigo, numbness, aphasia, dysarthria or central neurologic deficit secondary to vascular lesions of the brain such as hemorrhage, embolism, thrombosis, or rupturing aneurysm, that persist for > 72 hours.

    Measured: Up to 20 years

  8. Major bleeding

    Any bleeding event will be collected with following description; the amount of hemoglobin drop or transfusion, the site of bleeding, any further treatment for the bleeding.

    Measured: Up to 20 years

  9. Cardiovascular readmission

    Any readmission due to cardiovascular adverse event will be collected.

    Measured: Up to 20 years

Timeline

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

  1. First posted9 Apr 2019
  2. Study start5 Oct 2018
  3. Primary completionApr 2039 (estimated)
  4. Study completionApr 2039 (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
20,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03908463
Sponsor's protocol ID
4-2018-0759
Status last verified
Mar 2024
First submitted
17 Mar 2019
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cho S, Kang DY, Kim JS, Park DW, Kim IS, Kang TS, Ahn JM, Lee PH, Kang SJ, Lee SW, Kim YH, Lee CW, Park SW, Lee SJ, Hong SJ, Ahn CM, Kim BK, Ko YG, Choi D, Jang Y, Hong MK, Park SJ. Dual antiplatelet therapy after percutaneous coronary intervention for left main coronary artery disease. Rev Esp Cardiol (Engl Ed). 2023 Apr;76(4):245-252. doi: 10.1016/j.rec.2022.07.007. Epub 2022 Jul 27. English, Spanish.

    PubMed 35907438

  • Kim C, Kim JS, Kim H, Ahn SG, Cho S, Lee OH, Park JK, Shin S, Moon JY, Won H, Suh Y, Cho JR, Cho YH, Oh SJ, Lee BK, Hong SJ, Shin DH, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y. Consensus Decision-Making for the Management of Antiplatelet Therapy before Non-Cardiac Surgery in Patients Who Underwent Percutaneous Coronary Intervention With Second-Generation Drug-Eluting Stents: A Cohort Study. J Am Heart Assoc. 2021 Apr 20;10(8):e020079. doi: 10.1161/JAHA.120.020079. Epub 2021 Apr 10.

    PubMed 33843258

  • Kim C, Kim JS, Kim H, Ahn SG, Cho S, Lee OH, Park JK, Shin S, Moon JY, Won H, Suh Y, Cho JR, Cho YH, Oh SJ, Lee BK, Hong SJ, Shin DH, Ahn CM, Kim BK, Ko YG, Choi D, Hong MK, Jang Y. Patterns of Antiplatelet Therapy During Noncardiac Surgery in Patients With Second-Generation Drug-Eluting Stents. J Am Heart Assoc. 2020 Jun 2;9(11):e016218. doi: 10.1161/JAHA.119.016218. Epub 2020 May 16.

    PubMed 32419586

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease and Acute Coronary Syndrome, run by Yonsei University at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target lesion revascularization (time frame: Up to 20 years). The study lists 9 primary outcomes in all. 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 NCT03908463, 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 19 Mar 2024.

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