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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Sun Yat-sen University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01198405
First received: July 29, 2010
Last updated: September 9, 2010
Last verified: January 2008

July 29, 2010
September 9, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01198405 on ClinicalTrials.gov Archive Site
  • vascular endothelial function [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
  • cardiac structure and exercise tolerance [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
  • atherosclerosis [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    24-hour urinary protein/albumin by urinalysis
  • all-cause mortality [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • revascularization rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • rehospitalization rate [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • rate of acute myocardial infarction [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1050
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
Both
18 Years to 75 Years
No
Contact: Yan Zhang, M.D. +86-137-1123-4160 zhangyan1233456@163.com
Contact: Qiang Xie, M.D. +86-138-0273-9667 qiangxie2010@sohu.com
China
 
NCT01198405
SYSU-5010-2008
Yes
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