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

This study is currently recruiting participants.
Verified August 2013 by Sun Yat-sen University
Sponsor:
Information provided by (Responsible Party):
Yan Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01106495
First received: April 19, 2010
Last updated: August 7, 2013
Last verified: August 2013

April 19, 2010
August 7, 2013
May 2010
December 2013   (final data collection date for primary outcome measure)
Intima-medial thickness of cervical artery [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Intima-media thickness of cervical artery measured by Doppler ultrasound equipment
Same as current
Complete list of historical versions of study NCT01106495 on ClinicalTrials.gov Archive Site
vascular endothelial function and serum markers of inflammation [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
vascular endothelial function was assessed by flow mediated dilation.
vascular endothelial function and serum markers of inflammation [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
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

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 hours lasting 7 weeks
  • Drug: statin
    statin as the standard treatment of hypercholesterolemia
    Other Name: Simvastatin
  • Active Comparator: Enhanced External conterpulsation
    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.
    Interventions:
    • Device: Enhanced External Counterpulsation (EECP)
    • Drug: statin
  • Active Comparator: Cholesterol
    Cholesterol means the subjects whose LDL higher than 160 mg/dl.Statins are used to decrease the level of cholesterol.
    Intervention: Drug: statin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 20- 70 years old subjects whose LDL higher than 160mg/dl and intima-medial thickness of cervical artery higher than 75 percent of his age.

Exclusion Criteria:

  • presence of history of coronary disease, stroke or peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
Both
20 Years to 70 Years
Yes
Contact: Yan Zhang, MD 862087755766 ext 8161 Zhyan3@mail.sysu.edu.cn
China
 
NCT01106495
EECP-1
Yes
Yan Zhang, Sun Yat-sen University
Yan Zhang
Not Provided
Study Director: Hong MA, MD First Affiliated Hospital, Sun Yat-Sen University
Sun Yat-sen University
August 2013

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