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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014