KOMATE Registry: Korean Multicenter Angioplasty Team

March 17, 2024 updated by: Yonsei University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

20000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea
        • Contact:
          • Byeong-Keuk Kim, PhD
          • Phone Number: 82-2-2228-8460
          • Email: kimbk@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The patients who undergo percutaneous coronary intervention
The patients who undergo percutaneous coronary intervention will be enrolled.
Device: Percutaneous coronary intervention
All coronary intervention procedures will be performed according to current standard techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion revascularization
Time Frame: Up to 20 years

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.
Up to 20 years
Target vessel revascularization
Time Frame: Up to 20 years

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.
Up to 20 years
Stent thrombosis
Time Frame: Up to 20 years
Stent thrombosis is defined and discussed by the Academic Research Consortium
Up to 20 years
Myocardial infarction
Time Frame: Up to 20 years
Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
Up to 20 years
Death
Time Frame: Up to 20 years
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.
Up to 20 years
Non-target vessel revascularization
Time Frame: Up to 20 years
Any revascularization of target-vessel revascularization will be collected.
Up to 20 years
Cerebrovascular accident
Time Frame: Up to 20 years
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.
Up to 20 years
Major bleeding
Time Frame: Up to 20 years
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.
Up to 20 years
Cardiovascular readmission
Time Frame: Up to 20 years
Any readmission due to cardiovascular adverse event will be collected.
Up to 20 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2018

Primary Completion (Estimated)

April 1, 2039

Study Completion (Estimated)

April 1, 2039

Study Registration Dates

First Submitted

March 17, 2019

First Submitted That Met QC Criteria

April 7, 2019

First Posted (Actual)

April 9, 2019

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-0759

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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