KOMATE Registry: Korean Multicenter Angioplasty Team

• Sponsor: Yonsei University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03908463
• Collaborator: (none)
• Enrollment: 20,000
• Location: 1
• Anticipated Duration (Months): 371
• Patients Per Site Per Month: 53.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention	Device: Percutaneous coronary intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 20000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: KOMATE Registry: Korean Multicenter Angioplasty Team
• Actual Study Start Date: May 1, 2008
• Anticipated Primary Completion Date: Apr 1, 2039
• Anticipated Study Completion Date: Apr 1, 2039

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

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

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

3. Stent thrombosis [Up to 20 years]

   Stent thrombosis is defined and discussed by the Academic Research Consortium

4. Myocardial infarction [Up to 20 years]

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

5. Death [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.

6. Non-target vessel revascularization [Up to 20 years]

   Any revascularization of target-vessel revascularization will be collected.

7. Cerebrovascular accident [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.

8. Major bleeding [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.

9. Cardiovascular readmission [Up to 20 years]

   Any readmission due to cardiovascular adverse event will be collected.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Severance Cardiovascular Hospital Yonsei University College of Medicine, 250 Seongsanno, Seodaemun-gu 120-752 Seoul, South Korea	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT03908463
• Other Study ID Numbers: 4-2018-0759
• First Posted: Apr 9, 2019
• Last Update Posted: Jul 16, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Infarction

Study Results

No Results Posted as of Jul 16, 2020