Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 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: March 27, 2017
Last verified: March 2017

April 19, 2010
March 27, 2017
May 2010
October 2017   (Final data collection date for primary outcome measure)
Intima-medial thickness of cervical artery [ Time Frame: 7 weeks ]
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 ]
vascular endothelial function was assessed by flow mediated dilation.
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
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: No masking
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
    Other Name: EECP
  • Drug: Simvastatin
    Simvastatin 40 mg/d for 7 weeks
    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 theapy for 7 weeks. Simvastatin are used to decrease the level of cholesterol for 7 weeks.
    Interventions:
    • Device: Enhanced External Counterpulsation (EECP)
    • Drug: Simvastatin
  • Active Comparator: Cholesterol
    Cholesterol means the subjects whose LDL higher than 160 mg/dl. Simvastatins are used to decrease the level of cholesterol 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 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.
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Yes
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
No
Not Provided
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
March 2017

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