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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 April 2017 by Yan Zhang, 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: April 3, 2017
Last verified: April 2017
  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: Simvastatin

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Yan Zhang, Sun Yat-sen University:

Primary Outcome Measures:
  • Change in Intima-media thickness of the carotid artery [ Time Frame: 7 weeks ]
    Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks


Secondary Outcome Measures:
  • Change in vascular endothelial function [ Time Frame: 7 weeks ]
    Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery

  • Change in serum markers of inflammation [ Time Frame: 7 weeks ]
    Change from baseline in serum markers of inflammation and laboratory parameters


Estimated Enrollment: 150
Actual Study Start Date: May 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 1- hour session every working day over a 7 week period. Simvastatin is used to decrease cholesterol level for 7 weeks.
Device: Enhanced External Counterpulsation (EECP)
EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period
Other Name: EECP
Drug: Simvastatin
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
Other Name: Statin
Active Comparator: Control
Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
Drug: Simvastatin
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
Other Name: Statin

Detailed Description:
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   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Presence of history of coronary heart disease, stroke or atherosclerotic 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
Sun Yat-sen University
Investigators
Study Director: Hong Ma, MD First Affiliated Hospital, Sun Yat-Sen University
  More Information

Responsible Party: Yan Zhang, Associate 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: April 3, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yan Zhang, Sun Yat-sen University:
Atherosclerosis
Vascular Endothelium
Counterpulsation, External

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 21, 2017