The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
Primary Purpose
Headache, Migraine, MR-Angiography
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MR-angiography, GTN
Sponsored by
About this trial
This is an interventional diagnostic trial for Headache focused on measuring Headache, migraine, MR-angiography, healthy volunteers, GTN, Middle cerebral artery
Eligibility Criteria
Inclusion Criteria: healthy volunteers Exclusion Criteria: history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to >2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia.
Sites / Locations
Outcomes
Primary Outcome Measures
The primary endpoints were the difference between the area under the curve of the MCA area and the difference between the area under the curve of the diameter of the MCA on an active day and on a placebo day recorded over 60 mins.
Secondary Outcome Measures
The secondary endpoints were difference in the area under the curve for the relative changes in area in percent deviation from baseline, and the difference in headache response.
Full Information
NCT ID
NCT00256802
First Posted
November 21, 2005
Last Updated
March 30, 2009
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT00256802
Brief Title
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
Official Title
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2004
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Danish Headache Center
4. Oversight
5. Study Description
Brief Summary
To examine the ability of MRA to measure the effect of GTN on the intra-cranial vascular response during the GTN-induced headache in healthy volunteers.
Detailed Description
The only intra cranial structures innervated by sensory nerves, and therefore a possible source of the headpain are the meninges and the large intracerebral arteries. The dilatation of the cerebral vessels may not be the origin of the head pain per se, but measurements of the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and has helped elucidate the basis for the migraine aura (Olesen, Friberg et al. 1990). The effects of different signal molecules on the intra cerebral vasculature continue to be an important field in the migraine research, in the search for possible pain causing signaling molecules.
Therefore we have set up at study to examine if MR-Angiography (MRA) can be used for monitoring of the vascular response after challenge with the known vasodilator GTN. This drug was chosen because it is well characterized and a large body of evidence from earlier studies could serve as background data (Thomsen 1997).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine, MR-Angiography, Healthy Volunteers, GTN, Middle Cerebral Artery
Keywords
Headache, migraine, MR-angiography, healthy volunteers, GTN, Middle cerebral artery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
12 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MR-angiography, GTN
Primary Outcome Measure Information:
Title
The primary endpoints were the difference between the area under the curve of the MCA area and the difference between the area under the curve of the diameter of the MCA on an active day and on a placebo day recorded over 60 mins.
Secondary Outcome Measure Information:
Title
The secondary endpoints were difference in the area under the curve for the relative changes in area in percent deviation from baseline, and the difference in headache response.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteers
Exclusion Criteria:
history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to >2 g aspirin/day), pregnancy and all known contraindications for MR-examinations incl. claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Møller Hansen, MD
Organizational Affiliation
Danish Headache Center
Official's Role
Study Chair
12. IPD Sharing Statement
Links:
URL
http://www.glostruphospital.dk/danishheadachecenter/menu
Description
The homepage of the Danish headache center, Glostrup, Copenhagen, Denmark
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The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
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