Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006318
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-09-30
Brief Title:
Role of Prostaglandins in the Regulation of Brain Blood Flow
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Role of Prostaglandins in the Control of Cerebral Blood Flow During Hypercapnia and Functional Activation in Humans
Status:
COMPLETED
Status Verified Date:
2003-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CC-0226 | None | None | None |