search
Back to results

Role of Prostaglandins in the Regulation of Brain Blood Flow

Primary Purpose

Healthy, Hypercapnia

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Healthy focused on measuring Cerebral Blood Flow, CO2 Inhalation, Imaging, MRI, Perfusion, Functional Activation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Any healthy normal volunteer above the age of 18 who is capable of giving informed consent. EXCLUSION CRITERIA: 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).

Sites / Locations

  • Warren G. Magnuson Clinical Center (CC)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 30, 2000
Last Updated
March 3, 2008
Sponsor
National Institutes of Health Clinical Center (CC)
search

1. Study Identification

Unique Protocol Identification Number
NCT00006318
Brief Title
Role of Prostaglandins in the Regulation of Brain Blood Flow
Official Title
Role of Prostaglandins in the Control of Cerebral Blood Flow During Hypercapnia and Functional Activation in Humans
Study Type
Observational

2. Study Status

Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
September 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)

4. Oversight

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Hypercapnia
Keywords
Cerebral Blood Flow, CO2 Inhalation, Imaging, MRI, Perfusion, Functional Activation

7. Study Design

Enrollment
125 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Any healthy normal volunteer above the age of 18 who is capable of giving informed consent. EXCLUSION CRITERIA: 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).
Facility Information:
Facility Name
Warren G. Magnuson Clinical Center (CC)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10223523
Citation
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.
Results Reference
background
PubMed Identifier
8637870
Citation
Kaufmann 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.
Results Reference
background
PubMed Identifier
8352945
Citation
Yamagata 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.
Results Reference
background

Learn more about this trial

Role of Prostaglandins in the Regulation of Brain Blood Flow

We'll reach out to this number within 24 hrs