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

This study is currently recruiting participants.
Verified April 2017 by Yan Zhang, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01106495
First Posted: April 20, 2010
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Yan Zhang, Sun Yat-sen University
April 19, 2010
April 20, 2010
April 5, 2017
May 2010
October 2017   (Final data collection date for primary outcome measure)
Change in Intima-media thickness of the carotid artery [ Time Frame: 7 weeks ]
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
Intima-medial thickness of cervical artery [ Time Frame: 7 weeks ]
Intima-media thickness of cervical artery measured by Doppler ultrasound equipment
Complete list of historical versions of study NCT01106495 on ClinicalTrials.gov Archive Site
  • Change in vascular endothelial function [ Time Frame: 7 weeks ]
    Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery
  • Change in serum markers of inflammation [ Time Frame: 7 weeks ]
    Change from baseline in serum markers of inflammation and laboratory parameters
vascular endothelial function and serum markers of inflammation [ Time Frame: 7 weeks ]
vascular endothelial function was assessed by FMD.
Not Provided
Not Provided
 
Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis
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
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atherosclerosis
  • 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 Name: EECP
  • Drug: Simvastatin
    Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
    Other Name: Statin
  • 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.
    Interventions:
    • Device: Enhanced External Counterpulsation (EECP)
    • Drug: Simvastatin
  • Active Comparator: Control
    Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
    Intervention: Drug: Simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2018
October 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
No
Contact: Yan Zhang, MD 862087755766 ext 8161 Zhyan3@mail.sysu.edu.cn
China
 
 
NCT01106495
EECP-1
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yan Zhang, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Study Director: Hong Ma, MD First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP