Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis (SESA)

Study of the Effect of EECP on Subclinical Atherosclerosis

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

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Device: Enhanced External Counterpulsation (EECP); Drug: Simvastatin

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 Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat- sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Director: Hong Ma, MD, First Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2010
• Primary Completion (Actual): October 1, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: April 19, 2010
• First Posted (Estimate): April 20, 2010

Study Record Updates

• Last Update Posted (Actual): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Atherosclerosis; Vascular Endothelium; Counterpulsation, External
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: EECP-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No