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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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ECPT, endothelial progenitor cells

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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External counter pulsation therapy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jonathan Leor, Prof.

Role: PRINCIPAL_INVESTIGATOR

Chaim Sheba Medical Center

Locations

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Neufeld cardiac research institute, Sheba medical center

Tel Litwinsky, , Israel

Site Status

Countries

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Israel

Other Identifiers

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SHEBA-02-2701-JL-CTIL

Identifier Type: -

Identifier Source: org_study_id