Efficacy of Enhanced External Counterpulsation on Ventricular Function

Sun Yat-sen University150 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

150

Conditions

Coronary Heart Disease

Interventions

Experimental: Enhanced External CounterpulsationDEVICE

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.

Standard medical therapyDRUG

Guideline- driven standard medical treatment for 7 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change in heart function

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

Time frame: 7 weeks

Secondary Outcomes

Change in cardiac chamber diameter

Change from baseline in cardiac chamber diameterat 7 weeks

Time frame: 7 weeks

Change in ventricular wall thickness

Change from baseline in ventricular wall thickness

Time frame: 7 weeks

Data from ClinicalTrials.gov

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