Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status (EECPVHS)

Sun Yat-sen University

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: Medical therapy; Device: EECP

Study type: Interventional

Funder types: Other

Identifiers

NCT03102502

EECP- 2

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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110 participants in 2 patient groups

Enhanced External Counterpulsation

Experimental group

Description:

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.

Treatment:

Device: EECP

Drug: Medical therapy

Control

Active Comparator group

Description:

Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.

Treatment:

Drug: Medical therapy