Endothelial Progenitor Cells
Primary Purpose
Coronary Artery Disease
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
blood collecting
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Endothelial progenitor cell, coronary artery bypass
Eligibility Criteria
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
Sites / Locations
- Far Eastern Memorial HospitalRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01686269
First Posted
February 6, 2009
Last Updated
September 12, 2012
Sponsor
Far Eastern Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01686269
Brief Title
Endothelial Progenitor Cells
Official Title
Mobilization of Endothelial Progenitor Cells in Patients With Coronary Artery Bypass Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Far Eastern Memorial Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Endothelial progenitor cell, coronary artery bypass
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
blood collecting
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuan-MIng Chiu, MD
Phone
886-2-89667000
Email
kmchius@yahoo.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuan-Ming Chiu, MD
Organizational Affiliation
Far Eastern Memorial Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
220
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuan-Ming Chiu, MD
Phone
886-2-89667000
Email
kmchius@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Kuan-Ming Chiu, MD
12. IPD Sharing Statement
Learn more about this trial
Endothelial Progenitor Cells
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