Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Study Overview
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Brief Summary
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The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms

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. Hemodynamic parameters, vascular status and function will be measured.

Official Title
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Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: EECP
* Drug: 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 Arrythmias significantly interfere with the triggering of the EECP device History of cerebral hemorrhage Hemorrhagic disease Lower limb infection, phlebitis Deep venous thrombosis Malignant disease INR > 2.5 Uncontrolled hypertension, defined as SBP > 180mmHg or DBP > 110mmHg Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 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
Interventional Model Description: Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced External Counterpulsation<br>Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period. | Device: EECP<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 is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.<br>* Other names: Enhanced External Counterpulsation;Drug: Medical therapy<br>* Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）<br>* Other names: Guideline- driven medical therapy;|
| Active Comparator: Control<br>Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention. | Drug: Medical therapy<br>* Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）<br>* Other names: Guideline- driven medical therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood flow velocity | Change from baseline in blood flow velocity measured by color Doppler ultrasound system | At baseline, during EECP and week 7 (post intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in vascular endothelial function | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system | At baseline and week 7 (post intervention) | 
| Change in atherosclerosis | Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity | At baseline and week 7 (post intervention) | 

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