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NCT Number: NCT03102502

Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms

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Key information

Conditions

Coronary Heart Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

About this study

Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • More than 50% stenosis of left main trunk and 3 epicardial coronary arteries and their large branches showed by coronary angiography
  • Or history of myocardial infarction
  • Or history of prior revascularization
  • Signed informed consent to participate in the study

Exclusion criteria

  • Clinically significant valvular heart disease
  • Aortic aneurysm
  • Congenital heart disease
  • Acute myocarditis
  • Arrythmias significantly interfere with the triggering of the EECP device
  • History of cerebral hemorrhage
  • Hemorrhagic disease
  • Lower limb infection, phlebitis
  • Deep venous thrombosis
  • Malignant disease
  • INR > 2.5
  • Uncontrolled hypertension, defined as SBP > 180mmHg or DBP > 110mmHg
  • Pregnancy

Treatment and study plan

EECP

Device

Enhanced external counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.

Other names: Enhanced External Counterpulsation

Medical Therapy

Drug

Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）

Other names: Guideline- driven medical therapy

Primary outcomes

  1. Change in blood flow velocity

    Time frame: At baseline, during EECP and week 7 (post intervention)

    Change from baseline in blood flow velocity measured by color Doppler ultrasound system

Secondary outcomes

  1. Change in vascular endothelial function

    Time frame: At baseline and week 7 (post intervention)

    Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

  2. Change in atherosclerosis

    Time frame: At baseline and week 7 (post intervention)

    Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Acronym: EECPVHS

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 5, 2017
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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