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

Primary Purpose

Coronary Heart Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EECP
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, Atherosclerosis, Vascular Endothelium, Counterpulsation, External

Eligibility Criteria

20 Years - 80 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
  • 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

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

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.

Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.

Outcomes

Primary Outcome Measures

Change in blood flow velocity
Change from baseline in blood flow velocity measured by color Doppler ultrasound system

Secondary Outcome Measures

Change in vascular endothelial function
Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Change in atherosclerosis
Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity

Full Information

First Posted
March 31, 2017
Last Updated
October 29, 2020
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03102502
Brief Title
Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Acronym
EECPVHS
Official Title
Study of the Effects of Enhanced External Counterpulsation on Vascular Hemodynamics and Status
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
January 10, 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 present study aimed to investigated the effect of Enhanced External Counterpulsation (EECP) on vascular hemodynamics and atherosclerosis, and the underlying shear stress related mechanisms
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.

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, Atherosclerosis, Vascular Endothelium, Counterpulsation, External

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel: Patiants with coronary heart disease are assigned to two groups in parallel for the duration of the study.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced External Counterpulsation
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients receive guideline- driven standard medical therapy for 7 weeks without Enhanced External Counterpulsation intervention.
Intervention Type
Device
Intervention Name(s)
EECP
Other Intervention Name(s)
Enhanced External Counterpulsation
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 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.
Intervention Type
Drug
Intervention Name(s)
Medical therapy
Other Intervention Name(s)
Guideline- driven medical therapy
Intervention Description
Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
Primary Outcome Measure Information:
Title
Change in blood flow velocity
Description
Change from baseline in blood flow velocity measured by color Doppler ultrasound system
Time Frame
At baseline, during EECP and week 7 (post intervention)
Secondary Outcome Measure Information:
Title
Change in vascular endothelial function
Description
Change from baseline in flow- mediated dilation (FMD) accessed by color Doppler ultrasound system
Time Frame
At baseline and week 7 (post intervention)
Title
Change in atherosclerosis
Description
Change from baseline in atherosclerosis : plaque of common carotid artery, carotid intima- media thickness, pulse wave velocity
Time Frame
At baseline and week 7 (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 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 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
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
Citations:
PubMed Identifier
17936150
Citation
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. Erratum In: J Am Coll Cardiol. 2007 Dec 18;50(25):2441.
Results Reference
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PubMed Identifier
16979007
Citation
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.
Results Reference
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PubMed Identifier
20921442
Citation
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.
Results Reference
background
PubMed Identifier
17620513
Citation
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.
Results Reference
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Impact of Enhanced External Counterpulsation on Vascular Hemodynamics and Status

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