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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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 Intervention
Atherosclerosis
Device: Enhanced External Counterpulsation (EECP)
Drug: statin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of the Effect of EECP on Subclinical Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: Cholesterol
Cholesterol means the subjects whose LDL higher than 160 mg/dl.Statins are used to decrease the level of cholesterol.
Drug: statin
statin as the standard treatment of hypercholesterolemia
Other Name: Simvastatin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106495

Contacts
Contact: Yan Zhang, MD 862087755766 ext 8161 Zhyan3@mail.sysu.edu.cn

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat- sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Ling Zhang, MA    862087755766 ext 8035    Zhanglingaben@126.com   
Principal Investigator: Yan Zhang, MD         
Sponsors and Collaborators
Yan Zhang
Investigators
Study Director: Hong MA, MD First Affiliated Hospital, Sun Yat-Sen University
  More Information

No publications provided

Responsible Party: Yan Zhang, associated professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01106495     History of Changes
Other Study ID Numbers: EECP-1
Study First Received: April 19, 2010
Last Updated: August 7, 2013
Health Authority: China: National Natural Science Foundation

Keywords provided by Sun Yat-sen University:
atherosclerosis, endothelial, vascular, counterpulsation

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Arterial Occlusive Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014