The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
Tracking Information | |||||
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First Received Date ICMJE | November 21, 2005 | ||||
Last Updated Date | March 30, 2009 | ||||
Start Date ICMJE | June 2004 | ||||
Primary Completion Date | |||||
Current Primary Outcome Measures ICMJE |
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. | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00256802 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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. | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography | ||||
Official Title ICMJE | The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers. | ||||
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. |
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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). |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Diagnostic |
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Condition ICMJE |
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Intervention ICMJE | Device: MR-angiography, GTN | ||||
Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 12 | ||||
Completion Date | January 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 40 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT00256802 | ||||
Other Study ID Numbers ICMJE | MRA-GTN2004 | ||||
Has Data Monitoring Committee | |||||
Responsible Party | |||||
Study Sponsor ICMJE | Danish Headache Center | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Danish Headache Center | ||||
Verification Date | May 2004 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |