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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
History of Changes
  Purpose

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
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Biospecimen Retention:   Samples Without DNA

whole blood


Enrollment: 60
Study Start Date: July 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627068

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

No publications provided

Responsible Party: Yerem Yeghiazarians, Assistant Clinical Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00627068     History of Changes
Other Study ID Numbers: HL086917
Study First Received: February 21, 2008
Last Updated: September 16, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
cardiovascular
vasodilation
endothelium
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
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
 Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013