Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2023
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04043052 - Mobile Technologies and Post-stroke Depression N/A
Recruiting NCT03869138 - Alternative Therapies for Improving Physical Function in Individuals With Stroke N/A
Completed NCT04101695 - Hemodynamic Response of Anodal Transcranial Direct Current Stimulation Over the Cerebellar Hemisphere in Healthy Subjects N/A
Completed NCT04034069 - Effects of Priming Intermittent Theta Burst Stimulation on Upper Limb Motor Recovery After Stroke: A Randomized Controlled Trial N/A
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Completed NCT00391378 - Cerebral Lesions and Outcome After Cardiac Surgery (CLOCS) N/A
Recruiting NCT06204744 - Home-based Arm and Hand Exercise Program for Stroke: A Multisite Trial N/A
Active, not recruiting NCT06043167 - Clinimetric Application of FOUR Scale as in Treatment and Rehabilitation of Patients With Acute Cerebral Injury
Active, not recruiting NCT04535479 - Dry Needling for Spasticity in Stroke N/A
Completed NCT03985761 - Utilizing Gaming Mechanics to Optimize Telerehabilitation Adherence in Persons With Stroke N/A
Recruiting NCT00859885 - International PFO Consortium N/A
Recruiting NCT06034119 - Effects of Voluntary Adjustments During Walking in Participants Post-stroke N/A
Completed NCT03622411 - Tablet-based Aphasia Therapy in the Chronic Phase N/A
Completed NCT01662960 - Visual Feedback Therapy for Treating Individuals With Hemiparesis Following Stroke N/A
Recruiting NCT05854485 - Robot-Aided Assessment and Rehabilitation of Upper Extremity Function After Stroke N/A
Active, not recruiting NCT05520528 - Impact of Group Participation on Adults With Aphasia N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Completed NCT05805748 - Serious Game Therapy in Neglect Patients N/A
Recruiting NCT05993221 - Deconstructing Post Stroke Hemiparesis