Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis
SESA
Study of the Effect of EECP on Subclinical Atherosclerosis
1 other identifier
interventional
150
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2010
CompletedFirst Posted
Study publicly available on registry
April 20, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 2, 2020
October 1, 2020
8.4 years
April 19, 2010
October 29, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Intima-media thickness of the carotid artery
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
7 weeks
Secondary Outcomes (2)
Change in vascular endothelial function
7 weeks
Change in serum markers of inflammation
7 weeks
Study Arms (2)
Enhanced External Counterpulsation
EXPERIMENTALEnhanced 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.
Control
ACTIVE COMPARATORSubjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
Interventions
EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
Eligibility Criteria
You may qualify if:
- years old subjects whose LDL higher than 160mg/dl and carotid intima-media thickness higher than 75 percent of his age.
You may not qualify if:
- Presence of history of coronary heart disease, stroke or atherosclerotic peripheral disease. Presence of impaired renal function, connective disease, or infectious disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Sun Yat- sen University
Guangzhou, Guangdong, 510080, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hong Ma, MD
First Affiliated Hospital, Sun Yat-Sen University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
April 19, 2010
First Posted
April 20, 2010
Study Start
May 1, 2010
Primary Completion
October 1, 2018
Study Completion
January 1, 2020
Last Updated
November 2, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will not share