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
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
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
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
Learn more about this trial
Efficacy of Enhanced External Counterpulsation on Ventricular Function
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