Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

Study of the Effect of EECP on Subclinical Atherosclerosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01106495

Acronym

SESA

Enrollment

150

Registered

2010-04-20

Start date

2010-05-31

Completion date

2020-01-31

Last updated

2020-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Keywords

Atherosclerosis, Vascular Endothelium, Counterpulsation, External

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.

Interventions

DEVICEEnhanced External Counterpulsation (EECP)

EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period

DRUGSimvastatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change in Intima-media thickness of the carotid artery	7 weeks	Change from baseline in Intima-media thickness of the carotid artery measured by Doppler ultrasound equipment at 7 weeks

Secondary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026