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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00272571
• Lead Sponsor: Sheba Medical Center

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 Timeline

• Study Start: 2004-08
• Status Verified: 2006-01
• Study Completion: 2006-01
• Study First Submitted: 2006-01-04
• Study First Submitted QC: 2006-01-04
• Study First Posted: 2006-01-06
• Last Update Submitted: 2006-01-29
• Last Update Posted: 2006-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Neufeld cardiac research institute, Sheba medical center; 🇮🇱 Tel Hashomer, Israel