Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Change in blood flow velocity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 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
- •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
Arms & Interventions
Enhanced External Counterpulsation
Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.
Intervention: EECP (Device)
Enhanced External Counterpulsation
Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.
Intervention: Medical therapy (Drug)
Control
Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
Intervention: Medical therapy (Drug)
Outcomes
Primary Outcomes
Change in blood flow velocity
Time Frame: At baseline, during EECP and week 7 (post intervention)
Change from baseline in blood flow velocity measured by color Doppler ultrasound system
Secondary Outcomes
- Change in vascular endothelial function(At baseline and week 7 (post intervention))
- Change in atherosclerosis(At baseline and week 7 (post intervention))
Investigators
Yan Zhang
Associate Professor
Sun Yat-sen University