Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

Sun Yat-sen University110 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

110

Conditions

Coronary Heart Disease

Interventions

EECPDEVICE

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.

Medical therapyDRUG

Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 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 * 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

Locations (1)

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change in blood flow velocity

Change from baseline in blood flow velocity measured by color Doppler ultrasound system

Time frame: At baseline, during EECP and week 7 (post intervention)

Secondary Outcomes

Change in vascular endothelial function

Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

Time frame: 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

Time frame: At baseline and week 7 (post intervention)

Data from ClinicalTrials.gov

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