NCT01686269

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2009

Completed
3.6 years until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
Last Updated

September 18, 2012

Status Verified

January 1, 2007

First QC Date

February 6, 2009

Last Update Submit

September 12, 2012

Conditions

Keywords

Endothelial progenitor cellcoronary artery bypass

Interventions

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age from 18 to 85 years
  • signed written informed consent
  • angiographically documented coronary artery disease and indicated for coronary artery bypass surgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kuan-Ming Chiu, MD

    Far Eastern Memorial Hospital

    STUDY DIRECTOR

Central Study Contacts

Kuan-MIng Chiu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2009

First Posted

September 18, 2012

Study Start

March 1, 2007

Last Updated

September 18, 2012

Record last verified: 2007-01

Locations