IRM-DU: Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Unknown status
CT.gov ID
NCT03660852
Collaborator
(none)
380
1
23.3
16.3

Study Details

Study Description

Brief Summary

IRM-DU is a prospective observational single center study conducted in an emergency department to evaluate the impact of a MRI scanner exclusively dedicated to emergency in the clinical management of patients presenting with dizziness or diplopia.

The study will compare 2 strategies : after and before availability of a MRI scanner dedicated to emergency.

The primary endpoint is the proportion of patients with a diagnosis of stroke confirmed by imaging (MRI or Computed tomography (CT)) in the group "before implementation of the emergency MRI scanner" and the group "after implementation of the emergency MRI scanner".

The hypothesis is that the availability of a MRI scanner dedicated to emergency will improve the diagnosis of stroke in patients presenting with dizziness or diplopia, and will reduce Emergency Department stay, hospital stay and hospitalisation costs.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    380 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness
    Actual Study Start Date :
    Jul 24, 2018
    Anticipated Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Before dedicated MRI

    After dedicated MRI

    Outcome Measures

    Primary Outcome Measures

    1. Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed [18 months]

      Proportion of patients with a diagnosis of stroke confirmed by cerebral radiology (MRI or scan according to examination) in the pre- and post-MRI groups.

    Secondary Outcome Measures

    1. Evaluate the time of care [18 months]

      Evaluate the time of care: time of realization of the examination of radiology (scanner or brain MRI), delay of passage in emergencies

    2. Number of CT and brain MRI requested by the emergency physician in the before / after groups [18 months]

      Number of CT and brain MRI requested by the emergency physician in the before / after groups

    3. Evaluate the usual management of vertigo and diplopia [18 months]

      Evaluate the usual management of vertigo and diplopia: number of CT and brain MRI requested by the emergency physician in the "before / after" groups; number of cerebral CT and MRI performed by the radiologist in the "before / after" groups

    4. Evaluate the rate of new consultations in emergencies [18 months]

      Evaluate the rate of new consultations in emergencies for a neurological reason in the month following the initial care in emergencies, and the rate of new hospitalizations for the same reason

    5. Rate of new emergency department visits for neurological [the month following initial emergency care]

      Rate of new emergency department visits for neurological reasons in the month following initial emergency care

    6. Evaluate the irradiation rate [18 months]

      Evaluate the irradiation rate related to the initial radiological examination performed during emergency care

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • age over 18 years

    • non opponent to participate

    • dizziness or diplopia requiring brain imaging in order to eliminate stroke

    Exclusion Criteria:
    • opponent to participate

    • pregnant women

    • recent cerebral trauma

    • potentially eligible to thrombolysis

    • impaired consciousness

    • unable to give consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Les Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Sabrina GARNIER KEPKA, Les Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT03660852
    Other Study ID Numbers:
    • 7015
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    May 1, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 1, 2019