- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00512031
Characterizing PAI-1 Modulation on Monocyte Adhesion
July 15, 2011 updated by: Vanderbilt University
Characterizing the Effects of PAI-1 Modulation on Human Monocyte Function - The Effect of PAI-1 Post-transcriptional Regulation on Human Monocyte Adhesion
To determine how altering the expression of a gene known as PAI-1 may affect the adhesive capacity of cells that play a critical role in the developement of human atherosclerosis.
Study Overview
Status
Terminated
Conditions
Detailed Description
The principal aim of this study is to determine if molecular regulation of the human gene PAI-1 alters the migratory properties of human myeloid and endothelial cells sufficiently enough to regulate entry and exit from the vascular space.
Human monocyte become the key cellular orchestrators of human atherosclerotic plaque.
We believe that a "loss" of PAI-1 activity may promote a pro-atherogenic effect in human vasculature thereby defining a novel atheroprotective effect for PAI-1 when expressed at normal levels in humans.
By using RNA interference to achieve PAI-1 gene, we hope to elucidate the mechanistic basis of how PAI-1 regulation may affect human migration within the vasculature.
Study Type
Observational
Enrollment (Anticipated)
50
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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Tennessee
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Nashville, Tennessee, United States, 37232-6300
- Vanderbilt University Medical Center
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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 to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Healthy volunteers
Description
Inclusion Criteria:
- Ages 18-50
- No current or past medical problems
Exclusion Criteria:
- Patients taking prescription drugs (hormonal birth control or herbal supplements may be taken)
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
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohan Sathyamoorthy, MD, Vanderbilt University
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
January 1, 2007
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
August 3, 2007
First Submitted That Met QC Criteria
August 6, 2007
First Posted (Estimate)
August 7, 2007
Study Record Updates
Last Update Posted (Estimate)
July 18, 2011
Last Update Submitted That Met QC Criteria
July 15, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 070079
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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