A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change in heart function
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Enhanced External Counterpulsation
Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease
Intervention: Standard medical therapy (Drug)
Control
Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention
Intervention: Standard medical therapy (Drug)
Outcomes
Primary Outcomes
Change in heart function
Time Frame: 7 weeks
Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks
Secondary Outcomes
- Change in cardiac chamber diameter(7 weeks)
- Change in ventricular wall thickness(7 weeks)
Investigators
Yan Zhang
Associate professor
Sun Yat-sen University