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The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

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ClinicalTrials.gov Identifier: NCT00627068
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : September 20, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Cardiovascular Disease

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
Study Start Date : July 2007
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

High cardiovascular risk age over 61 years.
Low Cardiovascular risk age over 61.
High cardiovascular risk age over 25 but under 61.
Low cardiovascular risk age over 25 under 61.

Outcome Measures

Biospecimen Retention:   Samples Without DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Population in both low and high risk groups should represent the general population.

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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00627068

United States, California
UCSF, Department of Cardiology
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Principal Investigator: Yerem Yeghiazarians, M.D University of California, San Francisco
More Information

Responsible Party: Yerem Yeghiazarians, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00627068     History of Changes
Other Study ID Numbers: HL086917
First Posted: February 29, 2008    Key Record Dates
Last Update Posted: September 20, 2011
Last Verified: September 2011

Keywords provided by Yerem Yeghiazarians, University of California, San Francisco:
Subjects with high cardiovascular risk

Additional relevant MeSH terms:
Cardiovascular Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Protective Agents