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Endothelial Progenitor Cells

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
blood collecting
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Endothelial progenitor cell, coronary artery bypass

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 6, 2009
Last Updated
September 12, 2012
Sponsor
Far Eastern Memorial Hospital
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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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