Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

Study Overview
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Brief Summary
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To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.

Official Title
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A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Enhanced external counterpulsation
* Drug: Guideline-driven standard medical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least one coronary lesion of more than 50% stenosis shown by angiography history of acute myocardial infarction(at least one month before) history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting) typical angina episodes with evidence of myocardial ischemia Signed informed consent Exclusion Criteria: Obvious aortic insufficiency, aortic aneurysm, aortic dissection Coronary fistula or severe coronary aneurysm Symptomatic Congestive heart failure Valvular heart disease, congenital heart diseases, cardiomyopathies Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency; Lower limb infection, phlebitis, varicosity, deep venous thrombosis; Progressive malignancies or diseases with poor prognosis; uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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>Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy. | Device: Enhanced external counterpulsation<br>* Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.<br>|
| Active Comparator: Control<br>Guideline-driven standard medical therapy. | Drug: Guideline-driven standard medical therapy<br>* Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction |  | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vascular endothelial function | measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD) | up to 5 years | 
| cardiac structure and exercise tolerance | cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test | up to 5 years | 
| new-onset diabetes | fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c) | up to 5 years | 
| atherosclerosis | peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP) | up to 5 years | 
| 24-hour urinary protein | 24-hour urinary protein/albumin by urinalysis | up to 5 years | 
| all-cause mortality |  | up to 5 years | 
| revascularization rate |  | up to 5 years | 
| rehospitalization rate |  | up to 5 years | 
| rate of acute myocardial infarction |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, enhanced external counterpulsation