- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00627068
The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
September 16, 2011 updated by: Yerem Yeghiazarians, University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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San Francisco, California, United States, 94143
- UCSF, Department of Cardiology
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Population in both low and high risk groups should represent the general population.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
High cardiovascular risk age over 61 years.
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2
Low Cardiovascular risk age over 61.
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3
High cardiovascular risk age over 25 but under 61.
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4
Low cardiovascular risk age over 25 under 61.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yerem Yeghiazarians, M.D, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2010
Study Registration Dates
First Submitted
February 21, 2008
First Submitted That Met QC Criteria
February 28, 2008
First Posted (Estimate)
February 29, 2008
Study Record Updates
Last Update Posted (Estimate)
September 20, 2011
Last Update Submitted That Met QC Criteria
September 16, 2011
Last Verified
September 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL086917
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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