Clinical trial NCT03660852: Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Dizziness
Diplopia
MRI
Emergency Department
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care

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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed
timeFrame: 18 months
Secondary outcomes:
measure: Evaluate the time of care
timeFrame: 18 months
measure: Number of CT and brain MRI requested by the emergency physician in the before / after groups
timeFrame: 18 months
measure: Evaluate the usual management of vertigo and diplopia
timeFrame: 18 months
measure: Evaluate the rate of new consultations in emergencies
timeFrame: 18 months
measure: Rate of new emergency department visits for neurological
timeFrame: the month following initial emergency care
measure: Evaluate the irradiation rate
timeFrame: 18 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Sabrina GARNIER KEPKA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.