Efficacy of Enhanced External Counterpulsation on Ventricular Function (EECPVF)

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Device: Experimental: Enhanced External Counterpulsation; Drug: Standard medical therapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat- sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Enhanced External Counterpulsation; Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease	Device: Experimental: Enhanced External Counterpulsation; 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; Drug: Standard medical therapy; Guideline- driven standard medical treatment for 7 weeks; Other Names: Guideline- driven standard medical therapy
ACTIVE_COMPARATOR: Control; Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention	Drug: Standard medical therapy; Guideline- driven standard medical treatment for 7 weeks; Other Names: Guideline- driven standard medical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart function	Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cardiac chamber diameter	Change from baseline in cardiac chamber diameterat 7 weeks	7 weeks
Change in ventricular wall thickness	Change from baseline in ventricular wall thickness	7 weeks

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ACTUAL): December 30, 2018
• Study Completion (ACTUAL): March 30, 2019

Study Registration Dates

• First Submitted: April 4, 2017
• First Submitted That Met QC Criteria: April 4, 2017
• First Posted (ACTUAL): April 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Coronary Heart Disease; Ventricular Function; Vascular Endothelium; Counterpulsation, External
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: EECP-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No