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

September 9, 2010 updated by: Sun Yat-sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1050

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The 1st Affiliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhi-min Du, M.D.
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The 2nd Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Jing-feng Wang, M.D.
          • Phone Number: +86-136-0289-0860
        • Contact:
          • Ru-qiong Nie, M.D.
          • Phone Number: +86-136-0047-9016
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The 3rd affiliated hospital of Sun Yat-sen University
        • Contact:
          • Lin Chen, M.D.
          • Phone Number: +86-138-0251-8615
        • Contact:
          • Xiao-xian Qian, M.D.
          • Phone Number: +86-137-1926-1500
      • Zhuhai, Guangdong, China, 519000
        • Recruiting
        • The 5th Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Jian Peng, M.D.
          • Phone Number: +86-136-0036-1608

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
Time Frame: up to 5 years
up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vascular endothelial function
Time Frame: up to 5 years
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
up to 5 years
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
up to 5 years
new-onset diabetes
Time Frame: up to 5 years
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
up to 5 years
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)
up to 5 years
24-hour urinary protein
Time Frame: up to 5 years
24-hour urinary protein/albumin by urinalysis
up to 5 years
all-cause mortality
Time Frame: up to 5 years
up to 5 years
revascularization rate
Time Frame: up to 5 years
up to 5 years
rehospitalization rate
Time Frame: up to 5 years
up to 5 years
rate of acute myocardial infarction
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Anticipated)

September 1, 2010

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

July 29, 2010

First Submitted That Met QC Criteria

September 9, 2010

First Posted (Estimate)

September 10, 2010

Study Record Updates

Last Update Posted (Estimate)

September 10, 2010

Last Update Submitted That Met QC Criteria

September 9, 2010

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU-5010-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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