KOMATE Registry: Korean Multicenter Angioplasty Team

NCT03908463 | Recruiting

• 1 other identifier: 4-2018-0759
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (9)

• 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.

  Up to 20 years

• 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.

  Up to 20 years

• Stent thrombosis

  Stent thrombosis is defined and discussed by the Academic Research Consortium

  Up to 20 years

• Myocardial infarction

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

  Up to 20 years

• 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.

  Up to 20 years

• Non-target vessel revascularization

  Any revascularization of target-vessel revascularization will be collected.

  Up to 20 years

• 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.

  Up to 20 years

• 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.

  Up to 20 years

• Cardiovascular readmission

  Any readmission due to cardiovascular adverse event will be collected.

  Up to 20 years

Study Arms (1)

The patients who undergo percutaneous coronary intervention

The patients who undergo percutaneous coronary intervention will be enrolled.

Device: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention DEVICE

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

The patients who undergo percutaneous coronary intervention

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, South Korea

RECRUITING

Related Publications (3)

• 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.

  PMID: 35907438 DERIVED

• 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.

  PMID: 33843258 DERIVED

• 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.

  PMID: 32419586 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome; Myocardial Infarction

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: April 9, 2019
• Study Start: October 5, 2018
• Primary Completion (Estimated): April 1, 2039
• Study Completion (Estimated): April 1, 2039
• Last Updated: March 19, 2024

Record last verified: 2024-03

Locations

KR (1)