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:
Yan Zhang
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01106495
Contacts
| Contact: Yan Zhang, MD | 862087755766 ext 8141 | 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: | January 8, 2013 |
| Health Authority: | China: National Natural Science Foundation |
Keywords provided by Sun Yat-sen University:
|
atherosclerosis, endothelial, vascular, counterpulsation |
Additional relevant MeSH terms:
|
Atherosclerosis Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013