Efficacy of Enhanced External Counterpulsation on Ventricular Function
NCT ID: NCT03106116
Last Updated: 2020-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2017-03-15
2019-03-30
Brief Summary
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Detailed Description
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standard medical treatment and standard medical treatment plus EECP intervention. Ventricular structure and function will be measured and compared.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced External Counterpulsation
Experimental: Enhanced External Counterpulsation (EECP) intervention on top of guideline- driven standard medical therapy for coronary heart disease
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.
Standard medical therapy
Guideline- driven standard medical treatment for 7 weeks
Control
Guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention
Standard medical therapy
Guideline- driven standard medical treatment for 7 weeks
Interventions
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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.
Standard medical therapy
Guideline- driven standard medical treatment for 7 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Or history of myocardial infarction
* Or history of prior revascularization
* Signed informed consent to participate in the study
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Yan Zhang
Associate professor
Principal Investigators
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Yan Zhang, M. D.
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Sun Yat-Sen University
Zhensheng Zheng, M. D.
Role: STUDY_DIRECTOR
First Affiliated Hospital, Sun Yat-Sen University
Locations
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The First Affiliated Hospital, Sun Yat- sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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EECP-3
Identifier Type: -
Identifier Source: org_study_id