Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- cardiac death,
研究概览
简要总结
Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization. This study designed to evaluate the safety and efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.
详细描述
UCEPPCIOCT maintains a prospective clinical registry of all individual who undergo cardiac angiography,PCI or optimistic medicine treatment.
- research objective to observe the changes of cardiac function postoperative PCI in patients with CTO and the incidence of major adverse cardiovascular events, and provide the reality basis for PCI strategy in clinical patients with CTO . 2. research content: follow up the patients with CTO by using echocardiography in preoperative and postoperative PCI in 1m, 3ms, 6ms, 12ms to assess the changes of cardiac structure and cardiac function. 2, comparison the 'incidence of major adverse cardiovascular events undergo PCI treatment in success and failure group in patients with CTO (such as severe angina attack, severe acute coronary syndrome, severe heart failure should be rehospitalized , fatal arrhythmia and sudden cardiac death, etc.)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
masking for Ultrasonic Cardiogram investigator
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •coronary artery of chronic total occlusion
排除标准
- •ACS in 3months; once PCI or CABG; AF
研究组 & 干预措施
recanalisation CTO lesion successful
Patients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .
干预措施: stent (Device)
recanalisation CTO lesion failure
Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..
OMT
Patients with CTO lesion optimal medicine treatment without PCI
结局指标
主要结局
cardiac death,
时间窗: postoperation 1year
patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia
MACE
时间窗: postoperation 1year
recurrent severe angina, revascularization
次要结局
未报告次要终点
研究者
Genshan Ma
Director
Southeast University, China
