AtherosclerosisNCT00512369
Effects of PA-1 Transcriptional Regulation on Monocyte Function
An observational study of Atherosclerosis, run by Vanderbilt University at 1 site in United States.
Trial summary
Researching genetic differences in people with no prior medical conditions for better understanding of cardiac diseases through genetic research. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Jul 2011
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Obese men and women
Who may be able to join
- Ages 18 -50
- No current or past medical problems
Who cannot join
- Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Official title: Angiotensin, the Vascular Endothelium, and Fibrinolysis - The Effects of PAI-1 Transcriptional Regulation on Human Monocyte Function
Researching genetic differences in people with no prior medical conditions for better understanding of cardiac diseases through genetic research.
Read the detailed description
The discovery and subsequent application of small interfering RNA (siRNA) methods to achieve individual gene silencing in mammalian cells is a robust method that is well-described and validated in mammalian cell culture systems. We will apply this technique to achieve post-transcriptional "silencing" of PAI-1 in monocytes obtained from otherwise healthy volunteers, and study the subsequent loss of this gene's function on the migratory capacity of these cells in the proposed in vitro experimental system. This concept has not yet been demonstrated in the literature, and if validated, would be a novel and fundamental description of the role of PAI-1 in human monocyte biology as related to the development of atherosclerosis.
- Conditions
- Atherosclerosis
- Keywords
- Metabolic pathways, Atherosclerosis, Monocyte Function
- Medical subject headings
- Atherosclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2007 (estimated)
- Study startMar 2006
- Study completionJul 2011
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- Mohan Sathyamoorthy, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00512369
- Sponsor's protocol ID
- 060286
- Other IDs
- NIH
- Status last verified
- Jul 2011
- First submitted
- 3 Aug 2007
- Last updated
- 18 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Angiotensin, the Vascular Endothelium, and Fibrinolysis - The Effects of PAI-1 Transcriptional Regulation on Human Monocyte Function
- ClinicalTrials.gov ID
- NCT00512369
- Acronym / sponsor ID
- 060286
- Conditions
- Atherosclerosis
- Keywords
- Metabolic pathways, Atherosclerosis, Monocyte Function
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Mar 2006
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Aug 2007 (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.
Researching genetic differences in people with no prior medical conditions for better understanding of cardiac diseases through genetic research.
Detailed description
The discovery and subsequent application of small interfering RNA (siRNA) methods to achieve individual gene silencing in mammalian cells is a robust method that is well-described and validated in mammalian cell culture systems. We will apply this technique to achieve post-transcriptional "silencing" of PAI-1 in monocytes obtained from otherwise healthy volunteers, and study the subsequent loss of this gene's function on the migratory capacity of these cells in the proposed in vitro experimental system. This concept has not yet been demonstrated in the literature, and if validated, would be a novel and fundamental description of the role of PAI-1 in human monocyte biology as related to the development of atherosclerosis.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Obese men and women
Key inclusion criteria (2 listed)
- Ages 18 -50
- No current or past medical problems
Key exclusion criteria (1 listed)
- Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken.
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 was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 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.
Mohan Sathyamoorthy, MD principal investigator
Vanderbilt University
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 Atherosclerosis, run by Vanderbilt University 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 18 Jul 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 was stopped early (reason given: Investigator left institution). Results are not available in the source record.
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 18 Jul 2011.