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

Primary Purpose

Headache, Migraine, MR-Angiography

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MR-angiography, GTN
Sponsored by
Danish Headache Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Headache focused on measuring Headache, migraine, MR-angiography, healthy volunteers, GTN, Middle cerebral artery

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Outcomes

    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.

    Full Information

    First Posted
    November 21, 2005
    Last Updated
    March 30, 2009
    Sponsor
    Danish Headache Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00256802
    Brief Title
    The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography
    Official Title
    The Diameter of the Middle Cerebral Artery Measured With Magnetic Resonance Angiography (MRA) Under Provocation With Glyceryl Trinitrate in Healthy Volunteers.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2004
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Danish Headache Center

    4. Oversight

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Headache, Migraine, MR-Angiography, Healthy Volunteers, GTN, Middle Cerebral Artery
    Keywords
    Headache, migraine, MR-angiography, healthy volunteers, GTN, Middle cerebral artery

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    12 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Device
    Intervention Name(s)
    MR-angiography, GTN
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jakob Møller Hansen, MD
    Organizational Affiliation
    Danish Headache Center
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Links:
    URL
    http://www.glostruphospital.dk/danishheadachecenter/menu
    Description
    The homepage of the Danish headache center, Glostrup, Copenhagen, Denmark

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

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