Efficacy of Enhanced External Counterpulsation on Ventricular Function (EECPVF)

Sun Yat-sen University

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Drug: Standard medical therapy; Device: Experimental: Enhanced External Counterpulsation

Study type: Interventional

Funder types: Other

Identifiers

NCT03106116

EECP-3

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 90 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Enhanced External Counterpulsation

Experimental group

Description:

Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease

Treatment:

Device: Experimental: Enhanced External Counterpulsation

Drug: Standard medical therapy

Control

Active Comparator group

Description:

Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention

Treatment:

Drug: Standard medical therapy