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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

External counter pulsation therapy

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring ECPT, endothelial progenitor cells

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Neufeld cardiac research institute, Sheba medical center

Outcomes

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)

Full Information

NCT ID

NCT00272571

First Posted

January 4, 2006

Last Updated

January 29, 2006

Sponsor

Sheba Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00272571

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2006

Overall Recruitment Status

Completed

Study Start Date

August 2004 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sheba Medical Center

4. Oversight

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

ECPT, endothelial progenitor cells

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (false)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

External counter pulsation therapy

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Brachial artery endothelial function (before and one week after treatment)

Title

CCS angina class (before and one week after treatment)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Leor, Prof.

Organizational Affiliation

Chaim Sheba Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neufeld cardiac research institute, Sheba medical center

City

Tel Hashomer

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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