Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

Coronary Artery Disease Clinical Trial

— PROBE-EECP  

Official title:

A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01198405
• Other study ID #: SYSU-5010-2008
• Status: Recruiting
• Phase: N/A
• First received: July 29, 2010
• Last updated: September 9, 2010
• Start date: September 2008
• Est. completion date: September 2013

Study information

• Verified date: January 2008
• Source: Sun Yat-sen University
• Contact: Yan Zhang, M.D.
• Phone: +86-137-1123-4160
• Email: zhangyan1233456[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1050
• Est. completion date: September 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
China	The 1st Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The 2nd Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The 3rd Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong
China	The 5th Affiliated Hospital of Sun Yat-sen University	Zhuhai	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (9)

Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto R, Ferrans CE, Keller S. Effects of enhanced external counterpulsation on Health-Related Quality of Life continue 12 months after treatment: a substudy of the Multicenter Study of Enhanced External Counterpulsation. J Investig Med. 2002 Jan;50(1):25-32. — View Citation

Arora RR, Chou TM, Jain D, Fleishman B, Crawford L, McKiernan T, Nesto RW. The multicenter study of enhanced external counterpulsation (MUST-EECP): effect of EECP on exercise-induced myocardial ischemia and anginal episodes. J Am Coll Cardiol. 1999 Jun;33(7):1833-40. — View Citation

Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. Review. — View Citation

Kitsou V, Xanthos T, Roberts R, Karlis GM, Padadimitriou L. Enhanced external counterpulsation: mechanisms of action and clinical applications. Acta Cardiol. 2010 Apr;65(2):239-47. Review. — View Citation

Loh PH, Cleland JG, Louis AA, Kennard ED, Cook JF, Caplin JL, Barsness GW, Lawson WE, Soran OZ, Michaels AD. Enhanced external counterpulsation in the treatment of chronic refractory angina: a long-term follow-up outcome from the International Enhanced External Counterpulsation Patient Registry. Clin Cardiol. 2008 Apr;31(4):159-64. doi: 10.1002/clc.20117. — View Citation

Manchanda A, Soran O. Enhanced external counterpulsation and future directions: step beyond medical management for patients with angina and heart failure. J Am Coll Cardiol. 2007 Oct 16;50(16):1523-31. Epub 2007 Oct 1. Review. Erratum in: J Am Coll Cardiol. 2007 Dec 18;50(25):2441. — View Citation

Michaels AD, McCullough PA, Soran OZ, Lawson WE, Barsness GW, Henry TD, Linnemeier G, Ochoa A, Kelsey SF, Kennard ED. Primer: practical approach to the selection of patients for and application of EECP. Nat Clin Pract Cardiovasc Med. 2006 Nov;3(11):623-32. Review. — View Citation

Michaels AD, Raisinghani A, Soran O, de Lame PA, Lemaire ML, Kligfield P, Watson DD, Conti CR, Beller G. The effects of enhanced external counterpulsation on myocardial perfusion in patients with stable angina: a multicenter radionuclide study. Am Heart J. 2005 Nov;150(5):1066-73. — View Citation

O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. Epub 2006 Aug 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction		up to 5 years	No
Secondary	vascular endothelial function	measurment of flexibility of peripheral artery and flow-mediated dilatation (FMD)	up to 5 years	No
Secondary	cardiac structure and exercise tolerance	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	No
Secondary	new-onset diabetes	fasting, postprandial and random plasma glucose levels; glycosylated hemoglobin A1c (GHbA1c)	up to 5 years	No
Secondary	atherosclerosis	peripheral artery: plaque of common carotid artery, carotid intima-media Thickness, systolic and diastolic blood pressure (SBP & DBP)	up to 5 years	No
Secondary	24-hour urinary protein	24-hour urinary protein/albumin by urinalysis	up to 5 years	No
Secondary	all-cause mortality		up to 5 years	No
Secondary	revascularization rate		up to 5 years	No
Secondary	rehospitalization rate		up to 5 years	No
Secondary	rate of acute myocardial infarction		up to 5 years	No