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

January 29, 2006 updated by: Sheba Medical Center

The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Neufeld cardiac research institute, Sheba medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)

Secondary Outcome Measures

Outcome Measure
Brachial artery endothelial function (before and one week after treatment)
CCS angina class (before and one week after treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Jonathan Leor, Prof., Chaim Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion

December 7, 2022

Study Completion

January 1, 2006

Study Registration Dates

First Submitted

January 4, 2006

First Submitted That Met QC Criteria

January 4, 2006

First Posted (Estimate)

January 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 31, 2006

Last Update Submitted That Met QC Criteria

January 29, 2006

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-02-2701-JL-CTIL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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