The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function - Full Text View

Sponsored by:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00627068

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

Drug Information available for: Nitric oxide

U.S. FDA Resources

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

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

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

whole blood. Specifically EPC's.

Estimated Enrollment:	60
Study Start Date:	July 2007
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	February 2009 (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:

High and low cardiovascular risk subjects will be identified based on age or history of cardiovascular disease. Endothelial function will be measured by ultrasound.
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

Responsible Party:	UCSF ( Yarem Yeghiazarians, M.D )
Study ID Numbers:	HL086917
Study First Received:	February 21, 2008
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00627068
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

cardiovascular
vasodilation
endothelium
Subjects with high cardiovascular risk

Study placed in the following topic categories:

Nitric Oxide

Additional relevant MeSH terms:

Respiratory System Agents
Vasodilator Agents
Neurotransmitter Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents
Cardiovascular Agents
Protective Agents

Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Free Radical Scavengers
Endothelium-Dependent Relaxing Factors
Cardiovascular Diseases
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009