Clinical trial NCT01198405: Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
Official title: A Prospective,Randomized,Open-labeled,and Blind Endpoint Study of Enhanced External Counterpulsation for Patients With Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
enhanced external counterpulsation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction
timeFrame: up to 5 years
Secondary outcomes:
measure: vascular endothelial function
timeFrame: up to 5 years
measure: cardiac structure and exercise tolerance
timeFrame: up to 5 years
measure: new-onset diabetes
timeFrame: up to 5 years
measure: atherosclerosis
timeFrame: up to 5 years
measure: 24-hour urinary protein
timeFrame: up to 5 years
measure: all-cause mortality
timeFrame: up to 5 years
measure: revascularization rate
timeFrame: up to 5 years
measure: rehospitalization rate
timeFrame: up to 5 years
measure: rate of acute myocardial infarction
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The 2nd Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: The 3rd Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Zhuhai
country: China
facility: The 5th Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The 1st Affiliated Hospital of Sun Yat-sen University
name: Zhi-min Du, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The 1st Affiliated Hospital of Sun Yat-sen University
name: Gui-fu Wu, M.D. & Ph.D.
role: STUDY_DIRECTOR
References:
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.
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. doi: 10.2143/AC.65.2.2047060.
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. doi: 10.1016/j.jacc.2007.07.024. Epub 2007 Oct 1.
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. doi: 10.1038/ncpcardio0691.
citation: Cohn PF. Enhanced external counterpulsation for the treatment of angina pectoris. Prog Cardiovasc Dis. 2006 Sep-Oct;49(2):88-97. doi: 10.1016/j.pcad.2006.04.001.
citation: O'Rourke MF, Hashimoto J. Enhanced external counterpulsation why the benefit? J Am Coll Cardiol. 2006 Sep 19;48(6):1215-6. doi: 10.1016/j.jacc.2006.06.036. Epub 2006 Aug 28. No abstract available.
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. doi: 10.1016/j.ahj.2005.01.054.
citation: 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. doi: 10.2310/6650.2002.33514.
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. doi: 10.1016/s0735-1097(99)00140-0.