Healthy Clinical Trial
Official title:
Role of Prostaglandins in the Control of Cerebral Blood Flow During Hypercapnia and Functional Activation in Humans
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.
Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantify regional increases in cerebral blood flow. The purpose of this study is to investigate in humans the role of prostaglandins in the regulation of cerebral blood flow during hypercapnia and functional activation. For this investigation the increase in cerebral blood flow associated with either hypercapnia or functional activation will be measured before and after the administration of pharmacological agents that inhibit the production of prostaglandins. In the hypercapnia study cerebral blood flow will be increased by inhalation of an air mixture containing 6% CO2. For the functional activation study cerebral blood flow will be increased by a sensory motor task. ;
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