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

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00256802
First received: November 21, 2005
Last updated: March 30, 2009
Last verified: May 2004
  Purpose

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 Intervention
Headache
Migraine
MR-Angiography
Healthy Volunteers
GTN
Middle Cerebral Artery
Device: MR-angiography, GTN

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

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.

Estimated Enrollment: 12
Study Start Date: June 2004
Estimated Study Completion Date: January 2005
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).

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00256802

Sponsors and Collaborators
Danish Headache Center
Investigators
Study Chair: Jakob Møller Hansen, MD Danish Headache Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00256802     History of Changes
Other Study ID Numbers: MRA-GTN2004
Study First Received: November 21, 2005
Last Updated: March 30, 2009
Health Authority: Denmark: Den Centrale Videnskabsetiske Komité.

Keywords provided by Danish Headache Center:
Headache
migraine
MR-angiography
healthy volunteers
GTN
Middle cerebral artery

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014