Efficacy of Enhanced External Counterpulsation on Ventricular Function

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: Experimental: Enhanced External Counterpulsation
* Drug: Standard medical therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced External Counterpulsation<br>Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease | Device: Experimental: Enhanced External Counterpulsation<br>* 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.<br>* Other names: EECP;Drug: Standard medical therapy<br>* Guideline- driven standard medical treatment for 7 weeks<br>* Other names: Guideline- driven standard medical therapy;|
| Active Comparator: Control<br>Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention | Drug: Standard medical therapy<br>* Guideline- driven standard medical treatment for 7 weeks<br>* Other names: Guideline- driven standard medical therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External