Coronary Heart Disease
Conditions
Keywords
Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External
Brief summary
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
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.
Interventions
DEVICEExperimental: Enhanced External Counterpulsation
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.
DRUGStandard medical therapy
Guideline- driven standard medical treatment for 7 weeks
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in heart function | 7 weeks | Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac chamber diameter | 7 weeks | Change from baseline in cardiac chamber diameterat 7 weeks |
| Change in ventricular wall thickness | 7 weeks | Change from baseline in ventricular wall thickness |
Countries
China
Outcome results
None listed