Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Study of the Effect of EECP on Subclinical Atherosclerosis

Conditions
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Atherosclerosis

Intervention / Treatment
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* Device: Enhanced External Counterpulsation (EECP)
* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 20- 70 years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age. Exclusion Criteria: Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced External Counterpulsation<br>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. | Device: Enhanced External Counterpulsation (EECP)<br>* EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period<br>* Other names: EECP;Drug: Simvastatin<br>* Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment<br>* Other names: Statin;|
| Active Comparator: Control<br>Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks. | Drug: Simvastatin<br>* Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment<br>* Other names: Statin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intima-media thickness of the carotid artery | Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular endothelial function | Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery | 7 weeks | 
| Change in serum markers of inflammation | Change from baseline in serum markers of inflammation and laboratory parameters | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atherosclerosis, Vascular Endothelium, Counterpulsation, External