The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yerem Yeghiazarians, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00627068
First received: February 21, 2008
Last updated: September 16, 2011
Last verified: September 2011

February 21, 2008
September 16, 2011
July 2007
December 2010   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00627068 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

Our main hypothesis is that EPC function is impaired in some populations with high cardiovascular risk as a result of reduced eNOS-dependent NO production.

To determine if a correlation exists between EPC function and eNOS-dependent NO production in EPCs from populations with high versus low cardiovascular risk:

  1. High and low cardiovascular risk subjects will be identified based on age or history of cardiovascular disease. Endothelial function will be measured by ultrasound.
  2. EPCs will be isolated from peripheral blood of these subjects. EPC function will be assessed by measuring adhesion to endothelium, migration, proliferation, and differentiation, and compared to their expression and activity of eNOS.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

whole blood

Probability Sample

Population in both low and high risk groups should represent the general population.

Cardiovascular Disease
Not Provided
  • 1
    High cardiovascular risk age over 61 years.
  • 2
    Low Cardiovascular risk age over 61.
  • 3
    High cardiovascular risk age over 25 but under 61.
  • 4
    Low cardiovascular risk age over 25 under 61.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Willing and able to give written informed consent and comply with study requirements
  • Adult of 18 years or older
  • Subjects willing to provide blood and tissue samples

Exclusion Criteria:

  • Failure to give informed consent.
  • Those unable to consent for themselves.
  • Those who cannot read English.
  • Patients on Viagra, Levitra, or Cialis
  • Patients with malignant disease
  • Patients with hematological abnormalities
  • Patients with fevers of unknown origin
  • Severe comorbidity or alcohol/drug dependence
  • Women who are post-menopausal and on hormone replacement therapy, or premenopausal and on birth control pills (premenopausal women will be screened verbally and then by assay of LH and FSH levels in blood samples to identify women in the follicular phase of their menstrual cycle, to reduce variability)
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00627068
HL086917
Yes
Yerem Yeghiazarians, University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Yerem Yeghiazarians, M.D University of California, San Francisco
University of California, San Francisco
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP