Cardiovascular DiseaseNCT00627068
The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
An observational study of Cardiovascular Disease, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Population in both low and high risk groups should represent the general population.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF, Department of Cardiology
San Francisco, California, 94143
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular, vasodilation, endothelium, Subjects with high cardiovascular risk
- Medical subject headings
- Cardiovascular Diseases, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startJul 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yerem Yeghiazarians, University of California, San Francisco
- Investigators
- Yerem Yeghiazarians, M.D, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627068
- Sponsor's protocol ID
- HL086917
- Status last verified
- Sep 2011
- First submitted
- 21 Feb 2008
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nitric Oxide Synthase in Circulating Progenitor Cell Function
- ClinicalTrials.gov ID
- NCT00627068
- Acronym / sponsor ID
- HL086917
- Conditions
- Cardiovascular Disease
- Keywords
- cardiovascular, vasodilation, endothelium, Subjects with high cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Population in both low and high risk groups should represent the general population.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yerem Yeghiazarians, M.D principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2011.