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The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00256802
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : April 1, 2009
Information provided by:
Danish Headache Center

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.

Condition or disease Intervention/treatment Phase
Headache Migraine MR-Angiography Healthy Volunteers GTN Middle Cerebral Artery Device: MR-angiography, GTN Not Applicable

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 : Interventional  (Clinical Trial)
Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Diagnostic
Official Title: The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.
Study Start Date : June 2004
Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00256802

Sponsors and Collaborators
Danish Headache Center
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Study Chair: Jakob Møller Hansen, MD Danish Headache Center
Additional Information:
Layout table for additonal information Identifier: NCT00256802    
Other Study ID Numbers: MRA-GTN2004
First Posted: November 22, 2005    Key Record Dates
Last Update Posted: April 1, 2009
Last Verified: May 2004
Keywords provided by Danish Headache Center:
healthy volunteers
Middle cerebral artery
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms