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临床试验/NCT03300011
NCT03300011Unknown不适用

Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment

Southeast University, China1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年10月1日最近更新:
适应症
干预措施

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.

  1. 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

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

Experimental

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

No Intervention

Patients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..

OMT

No Intervention

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

发起方
Southeast University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Genshan Ma

Director

Southeast University, China

研究点 (1)

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