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The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells

This study has been completed.
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00272571
First received: January 4, 2006
Last updated: January 29, 2006
Last verified: January 2006
History of Changes
  Purpose

The objectives of the study are to test the hypothesis that external counter pulsation therapy (ECPT) provides clinical benefit by improving the number and function of endothelial progenitor cells (EPCs) in peripheral blood of patients with angina pectoris.


Condition Intervention
Coronary Artery Disease
 Procedure: External counter pulsation therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)

Secondary Outcome Measures:
  • Brachial artery endothelial function (before and one week after treatment)
  • CCS angina class (before and one week after treatment)

Estimated Enrollment: 25
Study Start Date: August 2004
Estimated Study Completion Date: January 2006
Detailed Description:

ECPT is a non-invasive approach for increasing blood flow to the heart in patients with myocardial ischemia. ECPT produces beneficial effects in coronary artery disease (CAD) patients. However, the exact mechanisms of ECPT action are not defined yet. Evidence has now accumulated that bone marrow-derived cells with angiogenic capability, termed EPCs, circulate in the blood of adults. EPCs possess the ability to home to sites of ischemia and contribute to neoangiogenesis.

We prospectively study CAD patients [Canadian Cardiovascular Society (CCS) angina class II-IV], before and after ECPT , and compare them with age- and sex-matched controls. Peripheral blood CD34+ cells, EPCs (CD34/VEGFR2+ cells), EPC colony forming units (CFUs) and brachial artery endothelial function is assessed prior to and after ECPT. Percent improvement in endothelium-dependent brachial artery flow-mediated dilatation (%FMD) is assessed using high-resolution ultrasound.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • coronary artery disease
  • CCS angina class II-IV

Exclusion Criteria:

  • aortic regurgitation
  • acute myocardial infarction <3 months
  • systemic hypertension >180/110 mm
  • atrial fibrillation
  • deep vein thrombosis
  • phlebitis and hemorrhagic diathesis
  • pregnancy
  • abdominal aortic aneurism
  • metastatic tumor
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272571

Locations
Israel
Neufeld cardiac research institute, Sheba medical center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Jonathan Leor, Prof. Chaim Sheba Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00272571     History of Changes
Other Study ID Numbers: SHEBA-02-2701-JL-CTIL
Study First Received: January 4, 2006
Last Updated: January 29, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
ECPT, endothelial progenitor cells

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013