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

NCT03660852 | Completed

• 1 other identifier: 7015
• Study Type: observational
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Dizziness; Diplopia; MRI; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Evaluate the time of care

  18 months

• 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

  18 months

• Evaluate the rate of new consultations in emergencies

  18 months

• Rate of new emergency department visits for neurological

  the month following initial emergency care

Study Arms (2)

Before dedicated MRI

After dedicated MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age over 18 years
• non opponent to participate
• dizziness or diplopia requiring brain imaging in order to eliminate stroke

You may not qualify if:

• opponent to participate
• pregnant women
• recent cerebral trauma
• potentially eligible to thrombolysis
• impaired consciousness
• unable to give consent

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Related Publications (1)

• 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.

  PMID: 35554653 DERIVED

MeSH Terms

Conditions

Stroke; Dizziness; Diplopia; Emergencies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vision Disorders; Eye Diseases; Disease Attributes; Pathologic Processes

Study Officials

• Sabrina GARNIER KEPKA

  Les Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: September 7, 2018
• Study Start: July 24, 2018
• Primary Completion: December 31, 2019
• Study Completion: January 24, 2020
• Last Updated: July 14, 2023

Record last verified: 2023-02

Locations

FR (1)