Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Atherosclerosis Clinical Trial

— SESA  

Official title:

Study of the Effect of EECP on Subclinical Atherosclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106495
• Other study ID #: EECP-1
• Status: Completed
• Phase: N/A
• Start date: May 2010
• Est. completion date: January 2020

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: January 2020
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

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

Drug:
• Simvastatin
Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat- sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in vascular endothelial function	Change from baseline in vascular endothelial function evaluated by flow mediated dilation of the brachial artery	7 weeks
Secondary	Change in serum markers of inflammation	Change from baseline in serum markers of inflammation and laboratory parameters	7 weeks