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

Sponsor
Sun Yat-sen University (Other)
Overall Status
Completed
CT.gov ID
NCT01106495
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
116
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Study of the Effect of EECP on Subclinical Atherosclerosis
Actual Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Oct 1, 2018
Actual Study Completion Date :
Jan 1, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Change in vascular endothelial function [7 weeks]

      Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery

    2. Change in serum markers of inflammation [7 weeks]

      Change from baseline in serum markers of inflammation and laboratory parameters

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Sun Yat- sen University Guangzhou Guangdong China 510080

    Sponsors and Collaborators

    • Sun Yat-sen University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yan Zhang, Associate professor, Sun Yat-sen University
    ClinicalTrials.gov Identifier:
    NCT01106495
    Other Study ID Numbers:
    • EECP-1
    First Posted:
    Apr 20, 2010
    Last Update Posted:
    Nov 2, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Yan Zhang, Associate professor, Sun Yat-sen University
    Atherosclerosis
    Vascular Endothelium
    Counterpulsation, External
    Additional relevant MeSH terms:
    Atherosclerosis
    Simvastatin

    Study Results

    No Results Posted as of Nov 2, 2020