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NCT Number: NCT01106495

Effect of Enhanced External Counterpulsation (EECP) on Subclinical Atherosclerosis

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

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Enhanced External Counterpulsation (EECP)

Device

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

Other names: EECP

simvastatin

Drug

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

Other names: Statin

Primary outcomes

  1. 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 outcomes

  1. 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

  2. Change in serum markers of inflammation

    Time frame: 7 weeks

    Change from baseline in serum markers of inflammation and laboratory parameters

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Study of the Effect of EECP on Subclinical Atherosclerosis

Acronym: SESA

Important dates

Study start
2010
Primary completion
2018
Study completion
2020
First posted
Apr 20, 2010
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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