Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, Atherosclerosis, Vascular Endothelium, Counterpulsation, External
Brief summary
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
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.
Interventions
DEVICEEECP
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.
DRUGMedical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood flow velocity | At baseline, during EECP and week 7 (post intervention) | Change from baseline in blood flow velocity measured by color Doppler ultrasound system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in vascular endothelial function | At baseline and week 7 (post intervention) | Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system |
| Change in atherosclerosis | At baseline and week 7 (post intervention) | Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity |
Countries
China
Outcome results
None listed