Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease
NCT ID: NCT01198405
Last Updated: 2010-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1050 participants
INTERVENTIONAL
2008-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Enhanced External Counterpulsation
Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.
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.
Control
Guideline-driven standard medical therapy.
Guideline-driven standard medical therapy
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
Interventions
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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.
Guideline-driven standard medical therapy
Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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The First Affiliated Hospital of Sun Yat-Sen University
Principal Investigators
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Zhi-min Du, M.D.
Role: PRINCIPAL_INVESTIGATOR
The 1st Affiliated Hospital of Sun Yat-sen University
Gui-fu Wu, M.D. & Ph.D.
Role: STUDY_DIRECTOR
The 1st Affiliated Hospital of Sun Yat-sen University
Locations
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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, China
Countries
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Central Contacts
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Facility Contacts
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Jing-feng Wang, M.D.
Role: primary
Ru-qiong Nie, M.D.
Role: backup
Lin Chen, M.D.
Role: primary
Xiao-xian Qian, M.D.
Role: backup
Jian Peng, M.D.
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SYSU-5010-2008
Identifier Type: -
Identifier Source: org_study_id