KOMATE Registry: Korean Multicenter Angioplasty Team

Recruiting

• Conditions: Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention
• Interventions: Device: Percutaneous coronary intervention

• Registration Number: NCT03908463
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-05
• Study First Submitted: 2019-03-17
• Study First Submitted QC: 2019-04-07
• Study First Posted: 2019-04-09
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19
• Primary Completion: 2039-04
• Study Completion: 2039-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The patients who undergo percutaneous coronary intervention	Percutaneous coronary intervention	The patients who undergo percutaneous coronary intervention will be enrolled.

Primary Outcome Measures

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

Trial Locations

Locations (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