Study of the Effect of EECP on Subclinical Atherosclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Intima-media thickness of the carotid artery
研究概览
简要总结
Shear stress maybe the most crucial local factor affecting atherogenesis. The present study investigated the effect of exposure to increased shear stress promoted by Enhanced External Counterpulsation (EECP) on the progression of subclinical atherosclerosis and the underlying inflammation- related molecular mechanisms
详细描述
Hypercholesterolemic subjects with subclinical atherosclerosis will be randomized into two groups: standard treatment group and standard treatment plus EECP intervention group. The results of ultrasound examination and markers of inflammations will be compared.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.
排除标准
- •Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
研究组 & 干预措施
Enhanced External Counterpulsation
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. Patients with subclinical atherosclerosis whose serum LDL high than 160mg/ml receive EECP 1- hour session every working day over a 7 week period. Simvastatin is used to decrease cholesterol level for 7 weeks.
干预措施: Enhanced External Counterpulsation (EECP) (Device)
Enhanced External Counterpulsation
Enhanced external counterpulsation (EECP) is a noninvasive therapy for the treatment of patients with coronary artery disease.The systolic deflation/diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. Patients with subclinical atherosclerosis whose serum LDL high than 160mg/ml receive EECP 1- hour session every working day over a 7 week period. Simvastatin is used to decrease cholesterol level for 7 weeks.
干预措施: Simvastatin (Drug)
Control
Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
干预措施: Simvastatin (Drug)
结局指标
主要结局
Change in Intima-media thickness of the carotid artery
时间窗: 7 weeks
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
次要结局
- Change in vascular endothelial function(7 weeks)
- Change in serum markers of inflammation(7 weeks)
研究者
Yan Zhang
Associate professor
Sun Yat-sen University