Skip to main content
OpenTrials
Completed

NCT Number: NCT03106116

Efficacy of Enhanced External Counterpulsation on Ventricular Function

The purpose of this study is to investigate the efficacy of Enhanced External Counterpulsation (EECP) therapy on ventricular function in patients with coronary heart disease

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–90 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. Ventricular structure and function will be measured and compared.

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
  • Arrhythmias significantly interfere with the triggering of the EECP device
  • History of cerebral hemorrhage
  • Hemorrhagic disease
  • Lower limb infection, phlebitis
  • Deep venous thrombosis
  • Malignant disease
  • International normalized ratio (INR) > 2.5
  • Uncontrolled hypertension, defined as systolic blood pressure > 180mmHg or diastolic blood pressure > 110mmHg
  • Pregnancy

Treatment and study plan

Experimental: Enhanced External Counterpulsation

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 has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.

Other names: EECP

Standard Medical Therapy

Drug

Guideline- driven standard medical treatment for 7 weeks

Other names: Guideline- driven standard medical therapy

Primary outcomes

  1. Change in heart function

    Time frame: 7 weeks

    Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks

Secondary outcomes

  1. Change in cardiac chamber diameter

    Time frame: 7 weeks

    Change from baseline in cardiac chamber diameterat 7 weeks

  2. Change in ventricular wall thickness

    Time frame: 7 weeks

    Change from baseline in ventricular wall thickness

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease

Acronym: EECPVF

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 10, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.