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

This study is currently recruiting participants.

Verified January 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: January 8, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

April 19, 2010

Last Updated Date

January 8, 2013

Start Date ^ICMJE

May 2010

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01106495 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

vascular endothelial function and serum markers of inflammation [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

vascular endothelial function was assessed by FMD.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Official Title ^ICMJE

Study of the Effect of EECP on Subclinical Atherosclerosis

Brief Summary

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Atherosclerosis

Intervention ^ICMJE

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

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

20 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Yan Zhang, MD

862087755766 ext 8141

Zhyan3@mail.sysu.edu.cn

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01106495

Other Study ID Numbers ^ICMJE

EECP-1

Has Data Monitoring Committee

Yes

Responsible Party

Yan Zhang, Sun Yat-sen University

Study Sponsor ^ICMJE

Yan Zhang

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hong MA, MD

First Affiliated Hospital, Sun Yat-Sen University

Information Provided By

Sun Yat-sen University

Verification Date

January 2013

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

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