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

Healthy Volunteers Clinical Trial

Official title:

The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00256802
• Other study ID #: MRA-GTN2004
• Status: Completed
• Phase: N/A
• First received: November 21, 2005
• Last updated: March 30, 2009
• Start date: June 2004
• Est. completion date: January 2005

Study information

• Verified date: May 2004
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Den Centrale Videnskabsetiske Komité.
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• GTN
• Headache
• Healthy Volunteers
• Middle Cerebral Artery
• Migraine
• MR-Angiography

Intervention

Device:
• MR-angiography, GTN

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.