Efficacy of Enhanced External Counterpulsation on Ventricular Function
Not Applicable
Completed
- Conditions
- Coronary Heart Disease
- Interventions
- Drug: Standard medical therapy
- Registration Number
- NCT03106116
- Lead Sponsor
- Sun Yat-sen University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Standard medical therapy Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention Enhanced External Counterpulsation Standard medical therapy Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease
- Primary Outcome Measures
Name Time Method Change in heart function 7 weeks Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The First Affiliated Hospital, Sun Yat- sen University
🇨🇳Guangzhou, Guangdong, China