Efficacy of Enhanced External Counterpulsation on Ventricular Function

Coronary Heart Disease Clinical Trial

— EECPVF  

Official title:

A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106116
• Other study ID #: EECP-3
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 30, 2019

Study information

• Verified date: October 2020
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: March 30, 2019
• Est. primary completion date: December 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• Experimental: Enhanced External Counterpulsation
Enhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.

Drug:
• Standard medical therapy
Guideline- driven standard medical treatment for 7 weeks

Locations

Country	Name	City	State
China	The First Affiliated Hospital, Sun Yat- sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart function	Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks	7 weeks
Secondary	Change in cardiac chamber diameter	Change from baseline in cardiac chamber diameterat 7 weeks	7 weeks
Secondary	Change in ventricular wall thickness	Change from baseline in ventricular wall thickness	7 weeks