The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

Cardiovascular Disease Clinical Trial

Official title:

The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627068
• Other study ID #: HL086917
• Status: Completed
• Phase: N/A
• First received: February 21, 2008
• Last updated: September 16, 2011
• Start date: July 2007
• Est. completion date: December 2010

Study information

• Verified date: September 2011
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Locations

Country	Name	City	State
United States	UCSF, Department of Cardiology	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States,