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

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00272571

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

MedlinePlus related topics: Angina Coronary Artery Disease

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

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

Keywords provided by Sheba Medical Center:

ECPT, endothelial progenitor cells

Study placed in the following topic categories:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Arteriosclerosis
Ischemia
Coronary Artery Disease

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Coronary Disease
Heart Diseases
Myocardial Ischemia

Vascular Diseases
Cardiovascular Diseases
Arteriosclerosis
Coronary Artery Disease

ClinicalTrials.gov processed this record on July 06, 2009