跳至主要内容
临床试验/NCT03908463
NCT03908463招募中不适用

KOMATE Registry: Korean Multicenter Angioplasty Team

Yonsei University1 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2018年10月5日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验