Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Change in blood flow velocity
研究概览
简要总结
The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms
详细描述
Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
- •Or history of myocardial infarction
- •Or history of prior revascularization
- •Signed informed consent to participate in the study
排除标准
- •Clinically significant valvular heart disease
- •Aortic aneurysm
- •Congenital heart disease
- •Acute myocarditis
- •Arrythmias significantly interfere with the triggering of the EECP device
- •History of cerebral hemorrhage
- •Hemorrhagic disease
- •Lower limb infection, phlebitis
- •Deep venous thrombosis
- •Malignant disease
- •INR > 2.5
- •Uncontrolled hypertension, defined as SBP > 180mmHg or DBP > 110mmHg
- •Pregnancy
研究组 & 干预措施
Enhanced External Counterpulsation
Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.
干预措施: EECP (Device)
Enhanced External Counterpulsation
Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.
干预措施: Medical therapy (Drug)
Control
Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
干预措施: Medical therapy (Drug)
结局指标
主要结局
Change in blood flow velocity
时间窗: At baseline, during EECP and week 7 (post intervention)
Change from baseline in blood flow velocity measured by color Doppler ultrasound system
次要结局
- Change in vascular endothelial function(At baseline and week 7 (post intervention))
- Change in atherosclerosis(At baseline and week 7 (post intervention))
研究者
Yan Zhang
Associate Professor
Sun Yat-sen University