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

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.

Study Overview

• Status: Completed
• Conditions: MRI; Stroke; Dizziness; Diplopia; Emergency Department

• Study Type: Observational
• Enrollment (Actual): 119

Contacts and Locations

• Study Contact: Name: Sabrina GARNIER KEPKA; Phone Number: + 33 3 69 55 13 35; Email: Sabrina.GARNIER-KEPKA@chru-strasbourg.fr

Study Locations

• France
  • Strasbourg, France, 67091
    • Les Hôpitaux Universitaires de Strasbourg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Primary care

All patients presented in ED with dizziness or diplopia are eligible to the study protocol

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Before dedicated MRI
After dedicated MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed	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.	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the time of care	Evaluate the time of care: time of realization of the examination of radiology (scanner or brain MRI), delay of passage in emergencies	18 months
Number of CT and brain MRI requested by the emergency physician in the before / after groups	Number of CT and brain MRI requested by the emergency physician in the before / after groups	18 months
Evaluate the usual management of vertigo and diplopia	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	18 months
Evaluate the rate of new consultations in emergencies	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	18 months
Rate of new emergency department visits for neurological	Rate of new emergency department visits for neurological reasons in the month following initial emergency care	the month following initial emergency care
Evaluate the irradiation rate	Evaluate the irradiation rate related to the initial radiological examination performed during emergency care	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Sabrina GARNIER KEPKA, Les Hôpitaux Universitaires de Strasbourg

Publications and helpful links

General Publications

• Kepka S, Zarca K, Lersy F, Moris M, Godet J, Deur J, Stoessel M, Muller J, Le Borgne P, Baloglu S, Fleury MC, Anheim M, Bilbault P, Bierry G, Durand Zaleski I, Kremer S. MRI dedicated to the emergency department for diplopia or dizziness: a cost-effectiveness analysis. Eur Radiol. 2022 Nov;32(11):7344-7353. doi: 10.1007/s00330-022-08791-7. Epub 2022 May 13.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 7, 2018

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Disease Attributes; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vision Disorders; Emergencies; Vertigo; Dizziness; Diplopia
• Other Study ID Numbers: 7015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No