- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00272571
The Effects of External Counter Pulsation Therapy on Circulating Endothelial Progenitor Cells
The Effects of External Counter Pulsation Therapy (ECPT) on the Number and Function of Circulating Endothelial Progenitor Cells in Patients With Angina Pectoris
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tel Hashomer, Israel
- Neufeld cardiac research institute, Sheba medical center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The number of circulating endothelial progenitor cells in peripheral blood (before and one week after treatment)
|
Secondary Outcome Measures
Outcome Measure |
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Brachial artery endothelial function (before and one week after treatment)
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CCS angina class (before and one week after treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jonathan Leor, Prof., Chaim Sheba Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-02-2701-JL-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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