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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00272571
• Other study ID #: SHEBA-02-2701-JL-CTIL
• Status: Completed
• Phase: N/A
• First received: January 4, 2006
• Last updated: January 29, 2006
• Start date: August 2004
• Est. completion date: January 2006

Study information

• Verified date: January 2006
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 90 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• External counter pulsation therapy

Locations

Country	Name	City	State
Israel	Neufeld cardiac research institute, Sheba medical center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)
Secondary	Brachial artery endothelial function (before and one week after treatment)
Secondary	CCS angina class (before and one week after treatment)