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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01198405

Collaborator

(none)

1,050

Enrollment

Locations

Arms

Duration (Months)

262.5

Patients Per Site

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Enhanced external counterpulsation Drug: Guideline-driven standard medical therapy	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1050 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Sep 1, 2010

Anticipated Study Completion Date :

Sep 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction [up to 5 years]

Secondary Outcome Measures

vascular endothelial function [up to 5 years]
measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)
cardiac structure and exercise tolerance [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 [up to 5 years]
fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)
atherosclerosis [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 [up to 5 years]
24-hour urinary protein/albumin by urinalysis
all-cause mortality [up to 5 years]
revascularization rate [up to 5 years]
rehospitalization rate [up to 5 years]
rate of acute myocardial infarction [up to 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The 1st Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080
2	The 2nd Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080
3	The 3rd Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510080
4	The 5th Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong	China	519000

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