KOMATE Registry: Korean Multicenter Angioplasty Team
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20,000
- 试验地点
- 1
- 主要终点
- Stent thrombosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 19 years
- •Patients who undergo percutaneous coronary intervention
排除标准
- •Refuse to participate
- •Pregnant women or women with potential childbearing
结局指标
主要结局
Stent thrombosis
时间窗: Up to 20 years
Stent thrombosis is defined and discussed by the Academic Research Consortium
Death
时间窗: 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
时间窗: 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
时间窗: Up to 20 years
Any readmission due to cardiovascular adverse event will be collected.
Target lesion revascularization
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Up to 20 years
Myocardial Infarction Classification and Criteria for Diagnosis is defined by the Academic Research Consortium
Non-target vessel revascularization
时间窗: Up to 20 years
Any revascularization of target-vessel revascularization will be collected.
次要结局
未报告次要终点
