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

Stroke Clinical Trial

— IRM-DU  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660852
• Other study ID #: 7015
• Status: Completed
• Start date: July 24, 2018
• Est. completion date: January 24, 2020

Study information

• Verified date: February 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: January 24, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diplopia
• Dizziness
• Emergencies
• Emergency Department
• MRI
• Stroke
• Vertigo

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Evaluate the irradiation rate	Evaluate the irradiation rate related to the initial radiological examination performed during emergency care	18 months