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

November 21, 2005
March 30, 2009
June 2004
 
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.
Same as current
Complete list of historical versions of study NCT00256802 on ClinicalTrials.gov Archive Site
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.
Same as current
 
 
 
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.

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.

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).

Interventional
 
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
  • Headache
  • Migraine
  • MR-Angiography
  • Healthy Volunteers
  • GTN
  • Middle Cerebral Artery
Device: MR-angiography, GTN
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
January 2005
 

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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00256802
MRA-GTN2004
 
 
Danish Headache Center
 
Study Chair: Jakob Møller Hansen, MD Danish Headache Center
Danish Headache Center
May 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP