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Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease (PROBE-EECP)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Enhanced external counterpulsation
Guideline-driven standard 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 Artery Disease focused on measuring coronary artery disease, enhanced external counterpulsation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least one coronary lesion of more than 50% stenosis shown by angiography
  • history of acute myocardial infarction(at least one month before)
  • history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting)
  • typical angina episodes with evidence of myocardial ischemia
  • Signed informed consent

Exclusion Criteria:

  • Obvious aortic insufficiency, aortic aneurysm, aortic dissection
  • Coronary fistula or severe coronary aneurysm
  • Symptomatic Congestive heart failure
  • Valvular heart disease, congenital heart diseases, cardiomyopathies
  • Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency;
  • Lower limb infection, phlebitis, varicosity, deep venous thrombosis;
  • Progressive malignancies or diseases with poor prognosis;
  • uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg

Sites / Locations

  • The 1st Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • The 2nd Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • The 3rd Affiliated Hospital of Sun Yat-sen UniversityRecruiting
  • The 5th Affiliated Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Enhanced External Counterpulsation

Control

Arm Description

Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.

Guideline-driven standard medical therapy.

Outcomes

Primary Outcome Measures

composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction

Secondary Outcome Measures

vascular endothelial function
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
cardiac structure and exercise tolerance
cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test
new-onset diabetes
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
atherosclerosis
peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP)
24-hour urinary protein
24-hour urinary protein/albumin by urinalysis
all-cause mortality
revascularization rate
rehospitalization rate
rate of acute myocardial infarction

Full Information

First Posted
July 29, 2010
Last Updated
September 9, 2010
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01198405
Brief Title
Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
Acronym
PROBE-EECP
Official Title
A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To investigate the mid- and long-term effect of Enhanced External Counterpulsation combined with guideline-driven standard treatment on patients documented with and/or at high risk of coronary artery disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery disease, enhanced external counterpulsation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1050 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Enhanced External Counterpulsation
Arm Type
Experimental
Arm Description
Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Guideline-driven standard medical therapy.
Intervention Type
Device
Intervention Name(s)
Enhanced external counterpulsation
Intervention Description
Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.
Intervention Type
Drug
Intervention Name(s)
Guideline-driven standard medical therapy
Intervention Description
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
Primary Outcome Measure Information:
Title
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
Time Frame
up to 5 years
Secondary Outcome Measure Information:
Title
vascular endothelial function
Description
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
Time Frame
up to 5 years
Title
cardiac structure and exercise tolerance
Description
cardiac chamber diameter, left ventricular wall thickness, ejection fraction, and etc., as deternmined by echocardiographic examination; exercise tolerance, as determined by Treadmill's Test
Time Frame
up to 5 years
Title
new-onset diabetes
Description
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
Time Frame
up to 5 years
Title
atherosclerosis
Description
peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP)
Time Frame
up to 5 years
Title
24-hour urinary protein
Description
24-hour urinary protein/albumin by urinalysis
Time Frame
up to 5 years
Title
all-cause mortality
Time Frame
up to 5 years
Title
revascularization rate
Time Frame
up to 5 years
Title
rehospitalization rate
Time Frame
up to 5 years
Title
rate of acute myocardial infarction
Time Frame
up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least one coronary lesion of more than 50% stenosis shown by angiography history of acute myocardial infarction(at least one month before) history of prior revascularization (Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting) typical angina episodes with evidence of myocardial ischemia Signed informed consent Exclusion Criteria: Obvious aortic insufficiency, aortic aneurysm, aortic dissection Coronary fistula or severe coronary aneurysm Symptomatic Congestive heart failure Valvular heart disease, congenital heart diseases, cardiomyopathies Cerebral hemorrhage within six months, bleeding disorders or identified bleeding tendency; Lower limb infection, phlebitis, varicosity, deep venous thrombosis; Progressive malignancies or diseases with poor prognosis; uncontrolled hypertension, defined as SBP≥180mmHg or DBP≥110mmHg
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Zhang, M.D.
Phone
+86-137-1123-4160
Email
zhangyan1233456@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qiang Xie, M.D.
Phone
+86-138-0273-9667
Email
qiangxie2010@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhi-min Du, M.D.
Organizational Affiliation
The 1st Affiliated Hospital of Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gui-fu Wu, M.D. & Ph.D.
Organizational Affiliation
The 1st Affiliated Hospital of Sun Yat-sen University
Official's Role
Study Director
Facility Information:
Facility Name
The 1st Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gui-fu Wu, M.D. & Ph.D.
Phone
+86-135-7001-0112
Email
eecpchina@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Da-ya Yang, M.D.
Phone
+86-135-7056-7490
Email
y2kchocolate@163.com
First Name & Middle Initial & Last Name & Degree
Zhi-min Du, M.D.
Facility Name
The 2nd Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jing-feng Wang, M.D.
Phone
+86-136-0289-0860
First Name & Middle Initial & Last Name & Degree
Ru-qiong Nie, M.D.
Phone
+86-136-0047-9016
Facility Name
The 3rd Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Chen, M.D.
Phone
+86-138-0251-8615
First Name & Middle Initial & Last Name & Degree
Xiao-xian Qian, M.D.
Phone
+86-137-1926-1500
Facility Name
The 5th Affiliated Hospital of Sun Yat-sen University
City
Zhuhai
State/Province
Guangdong
ZIP/Postal Code
519000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Peng, M.D.
Phone
+86-136-0036-1608

12. IPD Sharing Statement

Citations:
PubMed Identifier
18404725
Citation
Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117.
Results Reference
background
PubMed Identifier
20458834
Citation
Kitsou V, Xanthos T, Roberts R, Karlis GM, Padadimitriou L. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol. 2010 Apr;65(2):239-47. doi: 10.2143/AC.65.2.2047060.
Results Reference
background
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
background
PubMed Identifier
17063167
Citation
Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. doi: 10.1038/ncpcardio0691.
Results Reference
background
PubMed Identifier
17046434
Citation
Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. doi: 10.1016/j.pcad.2006.04.001.
Results Reference
background
PubMed Identifier
16979008
Citation
O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. doi: 10.1016/j.jacc.2006.06.036. Epub 2006 Aug 28. No abstract available.
Results Reference
background
PubMed Identifier
16291000
Citation
Michaels AD, Raisinghani A, Soran O, de Lame PA, Lemaire ML, Kligfield P, Watson DD, Conti CR, Beller G. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J. 2005 Nov;150(5):1066-73. doi: 10.1016/j.ahj.2005.01.054.
Results Reference
background
PubMed Identifier
11813825
Citation
Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R, Ferrans CE, Keller S. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. 2002 Jan;50(1):25-32. doi: 10.2310/6650.2002.33514.
Results Reference
background
PubMed Identifier
10362181
Citation
Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. doi: 10.1016/s0735-1097(99)00140-0.
Results Reference
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Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

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