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

This study is currently recruiting participants.
Verified January 2008 by Sun Yat-sen University
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
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
 Device: Enhanced external counterpulsation
Drug: Guideline-driven standard medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1050
Study Start Date: September 2008
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enhanced External Counterpulsation
Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
 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.
Active Comparator: Control
Guideline-driven standard medical therapy.
 Drug: Guideline-driven standard medical therapy
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01198405

Contacts
Contact: Yan Zhang, M.D. +86-137-1123-4160 zhangyan1233456@163.com
Contact: Qiang Xie, M.D. +86-138-0273-9667 qiangxie2010@sohu.com

Locations
China, Guangdong
The 1st Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Gui-fu Wu, M.D. & Ph.D.     +86-135-7001-0112     eecpchina@yahoo.com.cn    
Contact: Da-ya Yang, M.D.     +86-135-7056-7490     y2kchocolate@163.com    
Principal Investigator: Zhi-min Du, M.D.            
The 2nd Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jing-feng Wang, M.D.     +86-136-0289-0860        
Contact: Ru-qiong Nie, M.D.     +86-136-0047-9016        
The 3rd Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Lin Chen, M.D.     +86-138-0251-8615        
Contact: Xiao-xian Qian, M.D.     +86-137-1926-1500        
The 5th Affiliated Hospital of Sun Yat-sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Jian Peng, M.D.     +86-136-0036-1608        
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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
  More Information

Publications:

Responsible Party: Gui-Fu Wu, The First Affiliated Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01198405     History of Changes
Other Study ID Numbers: SYSU-5010-2008
Study First Received: July 29, 2010
Last Updated: September 9, 2010
Health Authority: China: Ministry of Health

Keywords provided by Sun Yat-sen University:
coronary artery disease
enhanced external counterpulsation

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on June 17, 2013