Stroke Clinical Trial
— IRM-DUOfficial title:
Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness
NCT number | NCT03660852 |
Other study ID # | 7015 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 24, 2018 |
Est. completion date | January 24, 2020 |
Verified date | February 2023 |
Source | University Hospital, Strasbourg, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Strasbourg, France |
France,
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 |
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