Role of Prostaglandins in the Regulation of Brain Blood Flow
2 other identifiers
observational
125
1 country
1
Brief Summary
This study will use magnetic resonance imaging (MRI) to examine the role of prostaglandins-a type of fatty acid with hormone-like actions-in the regulation of brain blood flow. The results will provide information on how to better use this technique to study brain function, which, in turn, may lead to a better understanding of certain illnesses and more effective treatments. Healthy normal volunteers 18 years of age and older may be eligible for this study. Participants will fill out a health questionnaire and undergo a history, physical examination and MRI studies. MRI is a diagnostic tool that uses a strong magnetic field and radio waves instead of X-rays to show structural and chemical changes in tissues. During the scanning, the subject lies on a table in a narrow cylinder containing a magnetic field. An intercom system allows the subject to speak with the staff member performing the study at all times during the procedure. Four separate studies will be done-two carbon dioxide inhalation studies and two functional activation studies-as follows: Carbon dioxide inhalation (indomethacin): This study is done in two parts. In both parts, an MRI brain scan is done. During the scan, the subject inhales an air mixture containing 6% carbon dioxide through a facemask or mouthpiece. Blood pressure and heart rate are monitored during inhalation of the mixture. For the second part of the study, indomethacin-a non-steroidal anti-inflammatory drug-is injected through a catheter (thin flexible tube) in an arm vein. Indomethacin inhibits prostaglandin production. Total scan time averages between 45 and 90 minutes, with a maximum of 2 hours. Carbon dioxide inhalation (rofecoxib and celecoxib): This study is identical to the one above, except either rofecoxib or celecoxib is given instead of indomethacin. Both of these drugs are also non-steroidal anti-inflammatory drugs that inhibit prostaglandin production. Unlike indomethacin, rofecoxib and celecoxib are given orally instead of through a vein, so, to allow time for the drug to be absorbed, the second scan is delayed for 2 hours. Functional activation (indomethacin): This study is done in two parts. In both parts, a MRI brain scan is done. During the study, the subject performs a simple motor task, such as finger tapping. For the second part of the study, indomethacin is injected through a catheter in an arm vein. Functional activation (rofecoxib and celecoxib): This study is identical to the indomethacin functional activation study, except either rofecoxib or celecoxib is given instead of indomethacin. Because they are given orally instead of through a vein, the second scan is delayed 2 hours to allow time for the drug to be absorbed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2000
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 30, 2000
CompletedFirst Posted
Study publicly available on registry
October 2, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedMarch 4, 2008
December 1, 2003
September 30, 2000
March 3, 2008
Conditions
Keywords
Eligibility Criteria
You may qualify if:
- Any healthy normal volunteer above the age of 18 who is capable of giving informed consent.
You may not qualify if:
- Subjects will be excluded for the following reasons.
- They have contraindications to MR scanning, such as the following: aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or autodefibrillator, cochlear implant, ocular foreign body (e.g., metal shavings), or insulin pump.
- They have panic disorder or migraine (because of possible complications with CO2 inhalation).
- They have cirrhosis, any renal dysfunction, or a chronic respiratory illness (such as asthma).
- They have allergies to sulfonamide drugs or cyclo-oxygenase inhibitors (NSAIDS).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Warren G. Magnuson Clinical Center (CC)
Bethesda, Maryland, 20892, United States
Related Publications (3)
O'Banion MK. Cyclooxygenase-2: molecular biology, pharmacology, and neurobiology. Crit Rev Neurobiol. 1999;13(1):45-82. doi: 10.1615/critrevneurobiol.v13.i1.30.
PMID: 10223523BACKGROUNDKaufmann WE, Worley PF, Pegg J, Bremer M, Isakson P. COX-2, a synaptically induced enzyme, is expressed by excitatory neurons at postsynaptic sites in rat cerebral cortex. Proc Natl Acad Sci U S A. 1996 Mar 19;93(6):2317-21. doi: 10.1073/pnas.93.6.2317.
PMID: 8637870BACKGROUNDYamagata K, Andreasson KI, Kaufmann WE, Barnes CA, Worley PF. Expression of a mitogen-inducible cyclooxygenase in brain neurons: regulation by synaptic activity and glucocorticoids. Neuron. 1993 Aug;11(2):371-86. doi: 10.1016/0896-6273(93)90192-t.
PMID: 8352945BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 30, 2000
First Posted
October 2, 2000
Study Start
September 1, 2000
Study Completion
December 1, 2003
Last Updated
March 4, 2008
Record last verified: 2003-12