Study of Enahnced External Counterpulsation to Treat Coronary Heart Disease

NCT01198405 | Unknown DMC

• 1 other identifier: SYSU-5010-2008
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 4

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.

Conditions

Coronary Artery Disease

Keywords

coronary artery disease; enhanced external counterpulsation

Outcome Measures

Primary Outcomes (1)

• composite endpoint of rate of all-cause mortality, revascularization, rehospitalization and acute myocardial infarction

  up to 5 years

Secondary Outcomes (9)

• vascular endothelial function

  up to 5 years

• cardiac structure and exercise tolerance

  up to 5 years

• new-onset diabetes

  up to 5 years

• atherosclerosis

  up to 5 years

• 24-hour urinary protein

  up to 5 years

Study Arms (2)

Enhanced External Counterpulsation

EXPERIMENTAL

Treatment of Enhanced External Counterpulsation (EECP) with a prespecified protocol on top of guideline-driven standard medical therapy.

Device: Enhanced external counterpulsation

Control

ACTIVE COMPARATOR

Guideline-driven standard medical therapy.

Drug: Guideline-driven standard medical therapy

Interventions

Enhanced external counterpulsation DEVICE

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.

Enhanced External Counterpulsation

Guideline-driven standard medical therapy DRUG

Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians

Control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (4)

The 1st Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The 2nd Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The 3rd Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The 5th Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 18404725 BACKGROUND

• 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.

  PMID: 20458834 BACKGROUND

• 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.

  PMID: 17936150 BACKGROUND

• 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.

  PMID: 17063167 BACKGROUND

• 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.

  PMID: 17046434 BACKGROUND

• 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.

  PMID: 16979008 BACKGROUND

• 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.

  PMID: 16291000 BACKGROUND

• 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.

  PMID: 11813825 BACKGROUND

• 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.

  PMID: 10362181 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Zhi-min Du, M.D.

  The 1st Affiliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

• Gui-fu Wu, M.D. & Ph.D.

  The 1st Affiliated Hospital of Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Yan Zhang, M.D.

CONTACT

+86-137-1123-4160; zhangyan1233456@163.com

Qiang Xie, M.D.

CONTACT

+86-138-0273-9667; qiangxie2010@sohu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2010
• First Posted: September 10, 2010
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2013
• Last Updated: September 10, 2010

Record last verified: 2008-01

Locations

CN (4)