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Efficacy of Enhanced External Counterpulsation on Ventricular Function (EECPVF)

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental: Enhanced External Counterpulsation
Standard medical therapy
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The First Affiliated Hospital, Sun Yat- sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced External Counterpulsation

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in cardiac chamber diameter
Change from baseline in cardiac chamber diameterat 7 weeks
Change in ventricular wall thickness
Change from baseline in ventricular wall thickness

Full Information

First Posted
April 4, 2017
Last Updated
October 29, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03106116
Brief Title
Efficacy of Enhanced External Counterpulsation on Ventricular Function
Acronym
EECPVF
Official Title
A Prospective, Randomized Study of Enhanced External Counterpulsation Therapy on Ventricular Function in Patients With Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
December 30, 2018 (Actual)
Study Completion Date
March 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Coronary Heart Disease, Ventricular Function, Vascular Endothelium, Counterpulsation, External

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced External Counterpulsation
Arm Type
Experimental
Arm Description
Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention
Intervention Type
Device
Intervention Name(s)
Experimental: Enhanced External Counterpulsation
Other Intervention Name(s)
EECP
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard medical therapy
Other Intervention Name(s)
Guideline- driven standard medical therapy
Intervention Description
Guideline- driven standard medical treatment for 7 weeks
Primary Outcome Measure Information:
Title
Change in heart function
Description
Change from baseline in heart function assessed by trans- thoracic echocardiography at 7 weeks
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Change in cardiac chamber diameter
Description
Change from baseline in cardiac chamber diameterat 7 weeks
Time Frame
7 weeks
Title
Change in ventricular wall thickness
Description
Change from baseline in ventricular wall thickness
Time Frame
7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Zhang, M. D.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhensheng Zheng, M. D.
Organizational Affiliation
First Affiliated Hospital, Sun Yat-Sen University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital, Sun Yat- sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of Enhanced External Counterpulsation on Ventricular Function

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