Efficacy of Enhanced External Counterpulsation on Ventricular Function

NCT03106116 | Completed DMC

• 1 other identifier: EECP-3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Heart Disease

Keywords

Coronary Heart Disease; Ventricular Function; Vascular Endothelium; Counterpulsation, External

Outcome Measures

Primary Outcomes (1)

• Change in heart function

  Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks

  7 weeks

Secondary Outcomes (2)

• Change in cardiac chamber diameter

  7 weeks

• Change in ventricular wall thickness

  7 weeks

Study Arms (2)

Enhanced External Counterpulsation

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

Drug: Standard medical therapy

Interventions

Experimental: Enhanced External Counterpulsation DEVICE

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.

Also known as: EECP

Enhanced External Counterpulsation

Standard medical therapy DRUG

Guideline- driven standard medical treatment for 7 weeks

Also known as: Guideline- driven standard medical therapy

Control; Enhanced External Counterpulsation

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital, Sun Yat- sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Yan Zhang, M. D.

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Zhensheng Zheng, M. D.

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: March 15, 2017
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: November 2, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)