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Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status (EECPVHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03102502
Recruitment Status : Unknown
Verified April 2018 by Yan Zhang, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : April 5, 2017
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Yan Zhang, Sun Yat-sen University

Brief Summary:
The present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: EECP Drug: Medical therapy Not Applicable

Detailed Description:
Patients with coronary heart disease will be randomized into two groups: standard medical treatment and standard medical treatment plus EECP intervention. Hemodynamic parameters, vascular status and function will be measured.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : October 10, 2018
Estimated Study Completion Date : January 10, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Device: 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.
Other Name: Enhanced External Counterpulsation

Drug: Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs(aspirin or Clopidogrel ), anti-ischemic drugs (Nitroglycerin)
Other Name: Guideline- driven medical therapy

Active Comparator: Control
Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
Drug: Medical therapy
Guideline- driven standard medical treatment including statins,antiplatelet drugs(aspirin or Clopidogrel ), anti-ischemic drugs (Nitroglycerin)
Other Name: Guideline- driven medical therapy




Primary Outcome Measures :
  1. Change in blood flow velocity [ Time Frame: At baseline, during EECP and week 7 (post intervention) ]
    Change from baseline in blood flow velocity measured by color Doppler ultrasound system


Secondary Outcome Measures :
  1. Change in vascular endothelial function [ Time Frame: At baseline and week 7 (post intervention) ]
    Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system

  2. Change in atherosclerosis [ Time Frame: At baseline and week 7 (post intervention) ]
    Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102502


Contacts
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Contact: Yan Zhang, M. D. 8620-87755766 ext 8161 zhyan3@mail.sysu.edu.cn
Contact: Qiang Xie, M. D. 8620-87755766 ext 8161 qiangxie@163.com

Locations
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China, Guangdong
The First Affiliated Hospital, Sun Yat- sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Weiwei Zhang, PhD    020-87334871    zhweiw2@mail.sysu.edu.cn   
Contact: Xiaoxu Zhou, PhD    020-87780263    xiaoxuzou_sysu@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yan Zhang, M. D. First Affiliated Hospital, Sun Yat-Sen University
Study Director: Zhensheng Zheng, M. D. First Affiliated Hospital, Sun Yat-Sen University
Publications:
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Responsible Party: Yan Zhang, Associate Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03102502    
Other Study ID Numbers: EECP- 2
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Zhang, Sun Yat-sen University:
Coronary Heart Disease
Atherosclerosis
Vascular Endothelium
Counterpulsation, External
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases