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

Tracking Information

First Received Date ^ICMJE

January 4, 2006

Last Updated Date

January 29, 2006

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00272571 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Procedure: External counter pulsation therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00272571

Responsible Party

Study ID Numbers ^ICMJE

SHEBA-02-2701-JL-CTIL

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Jonathan Leor, Prof.

Chaim Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

January 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP