Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
NCT ID: NCT03102502
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
110 participants
INTERVENTIONAL
2017-03-10
2019-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced External Counterpulsation
Patients receive a total of 35-36 hours of EECP treatment on top of guideline- driven standard medical therapy for coronary heart disease, 1-hour sessions every day over a 7-week period.
EECP
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 is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.
Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
Control
Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
Interventions
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EECP
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 is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.
Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
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
* Arrythmias significantly interfere with the triggering of the EECP device
* History of cerebral hemorrhage
* Hemorrhagic disease
* Lower limb infection, phlebitis
* Deep venous thrombosis
* Malignant disease
* INR \> 2.5
* Uncontrolled hypertension, defined as SBP \> 180mmHg or DBP \> 110mmHg
* Pregnancy
20 Years
80 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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References
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Manchanda A, Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1523-31. doi: 10.1016/j.jacc.2007.07.024. Epub 2007 Oct 1.
Nichols WW, Estrada JC, Braith RW, Owens K, Conti CR. Enhanced external counterpulsation treatment improves arterial wall properties and wave reflection characteristics in patients with refractory angina. J Am Coll Cardiol. 2006 Sep 19;48(6):1208-14. doi: 10.1016/j.jacc.2006.04.094. Epub 2006 Aug 28.
Braith RW, Conti CR, Nichols WW, Choi CY, Khuddus MA, Beck DT, Casey DP. Enhanced external counterpulsation improves peripheral artery flow-mediated dilation in patients with chronic angina: a randomized sham-controlled study. Circulation. 2010 Oct 19;122(16):1612-20. doi: 10.1161/CIRCULATIONAHA.109.923482. Epub 2010 Oct 4.
Zhang Y, He X, Chen X, Ma H, Liu D, Luo J, Du Z, Jin Y, Xiong Y, He J, Fang D, Wang K, Lawson WE, Hui JC, Zheng Z, Wu G. Enhanced external counterpulsation inhibits intimal hyperplasia by modifying shear stress responsive gene expression in hypercholesterolemic pigs. Circulation. 2007 Jul 31;116(5):526-34. doi: 10.1161/CIRCULATIONAHA.106.647248. Epub 2007 Jul 9.
Other Identifiers
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EECP- 2
Identifier Type: -
Identifier Source: org_study_id