- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01686269
Endothelial Progenitor Cells
September 12, 2012 updated by: Far Eastern Memorial Hospital
Mobilization of Endothelial Progenitor Cells in Patients With Coronary Artery Bypass Surgery
Vascular stenosis as a result of neointimal hyperplasia is a major clinical problem that has an impact on multiple and diverse disciplines, including cardiology (coronary restenosis), cardiothoracic and vascular surgery (saphenous vein and polytetrafluoroethylene [PTFE] graft failure), neurology (carotid stenosis), nephrology (dialysis access dysfunction), and transplant medicine (chronic allograft rejection in hearts and kidneys).
[1] In marked contrast to the deleterious effects of smooth muscle progenitor cells on neointimal hyperplasia, circulating endothelial progenitor cells (EPCs) are believed to play an important role in vascular repair and in the inhibition of neointimal hyperplasia.
[2] Endothelial progenitor cells (EPCs) circulate in adult peripheral blood and contribute to neovascularization.
Satoshi et al. have demonstrated that lineage-committed EPCs and CD34-positive mononuclear cells, their putative precursors, are mobilized during an acute ischemic event in humans.
[3] Reduced levels of circulating EPCs independently predict atherosclerotic disease progression, thus supporting an important role for endogenous vascular repair to modulate the clinical course of coronary artery disease.
[4] These observations prompt the hypothesis that circulating EPCs may provide an endogenous repair mechanism to counteract surgery-induced endothelial cell injury and to replace dysfunctional endothelium perioperatively.
Therefore, the investigators examined whether levels of circulating EPCs correlate with time course and outcomes of coronary artery bypass surgery to establish a clinical role of endogenous endothelial repair mediated by circulating EPCs.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 220
- Recruiting
- Far Eastern Memorial Hospital
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Contact:
- Kuan-Ming Chiu, MD
- Phone Number: 886-2-89667000
- Email: kmchius@yahoo.com.tw
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Principal Investigator:
- Kuan-Ming Chiu, MD
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age from 18 to 85 years
- signed written informed consent
- angiographically documented coronary artery disease and indicated for coronary artery bypass surgery
Exclusion Criteria:
- clinical or biochemical evidence for the presence of concomitant inflammatory disease
- chronic renal insufficiency (serum creatinine > 1.4 mmol/L)
- impaired left ventricular ejection fraction (< 45%)
- autoimmune or malignant disease
- thrombocytopenia (< 100 000/L)
- anemia (hemoglobin < 8.5 g/dL)
- inability to understand the consent form
- previous coronary bypass surgery
- severe peripheral arterial occlusive disease or atrial fibrillation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Kuan-Ming Chiu, MD, Far Eastern Memorial Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2007
Study Registration Dates
First Submitted
February 6, 2009
First Submitted That Met QC Criteria
September 12, 2012
First Posted (Estimate)
September 18, 2012
Study Record Updates
Last Update Posted (Estimate)
September 18, 2012
Last Update Submitted That Met QC Criteria
September 12, 2012
Last Verified
January 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FEMH-95-C-018
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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