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

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced External Counterpulsation (EECP)
Simvastatin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atherosclerosis focused on measuring Atherosclerosis, Vascular Endothelium, Counterpulsation, External

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital of Sun Yat- sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced External Counterpulsation

Control

Arm Description

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.

Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in vascular endothelial function
Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery
Change in serum markers of inflammation
Change from baseline in serum markers of inflammation and laboratory parameters

Full Information

First Posted
April 19, 2010
Last Updated
October 29, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01106495
Brief Title
Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis
Acronym
SESA
Official Title
Study of the Effect of EECP on Subclinical Atherosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis
Keywords
Atherosclerosis, Vascular Endothelium, Counterpulsation, External

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced External Counterpulsation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Subjects whose LDL higher than 160 mg/dl with subclinical atherosclerosis. Simvastatin is used to decrease cholesterol level for 7 weeks.
Intervention Type
Device
Intervention Name(s)
Enhanced External Counterpulsation (EECP)
Other Intervention Name(s)
EECP
Intervention Description
EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Statin
Intervention Description
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
Primary Outcome Measure Information:
Title
Change in Intima-media thickness of the carotid artery
Description
Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Change in vascular endothelial function
Description
Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery
Time Frame
7 weeks
Title
Change in serum markers of inflammation
Description
Change from baseline in serum markers of inflammation and laboratory parameters
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong Ma, MD
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat- sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

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