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

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. Identifier: NCT01198405
Recruitment Status : Unknown
Verified January 2008 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : September 10, 2010
Last Update Posted : September 10, 2010
Information provided by:
Sun Yat-sen University

July 29, 2010
September 10, 2010
September 10, 2010
September 2008
September 2010   (Final data collection date for primary outcome measure)
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction [ Time Frame: up to 5 years ]
Same as current
No Changes Posted
  • vascular endothelial function [ Time Frame: up to 5 years ]
    measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
  • cardiac structure and exercise tolerance [ Time Frame: up to 5 years ]
    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 [ Time Frame: up to 5 years ]
    fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
  • atherosclerosis [ Time Frame: up to 5 years ]
    peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP)
  • 24-hour urinary protein [ Time Frame: up to 5 years ]
    24-hour urinary protein/albumin by urinalysis
  • all-cause mortality [ Time Frame: up to 5 years ]
  • revascularization rate [ Time Frame: up to 5 years ]
  • rehospitalization rate [ Time Frame: up to 5 years ]
  • rate of acute myocardial infarction [ Time Frame: up to 5 years ]
Same as current
Not Provided
Not Provided
Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Coronary Artery Disease
  • Device: Enhanced external counterpulsation
    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.
  • Drug: Guideline-driven standard medical therapy
    Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
  • Experimental: Enhanced External Counterpulsation
    Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
    Intervention: Device: Enhanced external counterpulsation
  • Active Comparator: Control
    Guideline-driven standard medical therapy.
    Intervention: Drug: Guideline-driven standard medical therapy

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
September 2013
September 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Gui-Fu Wu, The First Affiliated Hospital of Sun Yat-Sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Zhi-min Du, M.D. The 1st Affiliated Hospital of Sun Yat-sen University
Study Director: Gui-fu Wu, M.D. & Ph.D. The 1st Affiliated Hospital of Sun Yat-sen University
Sun Yat-sen University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP