Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Device: Enhanced External Counterpulsation (EECP); Drug: Simvastatin

• Registration Number: NCT01106495
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-04-19
• Study First Posted: 2010-04-20
• Study Start: 2010-05
• Primary Completion: 2018-10
• Study Completion: 2020-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-29
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced External Counterpulsation	Enhanced External Counterpulsation (EECP)	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.
Control	Simvastatin	Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
Enhanced External Counterpulsation	Simvastatin	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.

Primary Outcome Measures

Name	Time	Method
Change in Intima-media thickness of the carotid artery	7 weeks	Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks

Secondary Outcome Measures

Name	Time	Method
Change in vascular endothelial function	7 weeks	Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery
Change in serum markers of inflammation	7 weeks	Change from baseline in serum markers of inflammation and laboratory parameters

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat- sen University; 🇨🇳 Guangzhou, Guangdong, China