StrokeIRM-DUNCT03660852
Impact of a Magnetic Resonance Imaging (MRI) Scanner Exclusively Dedicated to Emergency in the Clinical Management of Patients Presenting With Diplopia or Dizziness
An observational study of Stroke and Dizziness, run by University Hospital, Strasbourg, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 119 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jul 2018to 24 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care All patients presented in ED with dizziness or diplopia are eligible to the study protocol
Who may be able to join
- age over 18 years
- non opponent to participate
- dizziness or diplopia requiring brain imaging in order to eliminate stroke
Who cannot join
- opponent to participate
- pregnant women
- recent cerebral trauma
- potentially eligible to thrombolysis
- impaired consciousness
- unable to give consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Medical subject headings
- Stroke, Dizziness, Diplopia, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Before dedicated MRI | Not described | |
| After dedicated MRI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months
Secondary outcomes (6)
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
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
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
Measured: 18 months
Rate of new emergency department visits for neurological
Rate of new emergency department visits for neurological reasons in the month following initial emergency care
Measured: the month following initial emergency care
Evaluate the irradiation rate
Evaluate the irradiation rate related to the initial radiological examination performed during emergency care
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start24 Jul 2018
- Primary completion31 Dec 2019
- Study completion24 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabrina GARNIER KEPKA, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660852
- Sponsor's protocol ID
- 7015
- Acronym
- IRM-DU
- Status last verified
- Feb 2023
- First submitted
- 23 Jul 2018
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35554653
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03660852
- Acronym / sponsor ID
- IRM-DU / 7015
- Conditions
- Stroke, Dizziness, Diplopia, MRI, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 24 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 24 Jan 2020 (actual)
- First posted
- 7 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before dedicated MRI | – | – |
| After dedicated MRI | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care All patients presented in ED with dizziness or diplopia are eligible to the study protocol
Key inclusion criteria (3 listed)
- age over 18 years
- non opponent to participate
- dizziness or diplopia requiring brain imaging in order to eliminate stroke
Key exclusion criteria (6 listed)
- opponent to participate
- pregnant women
- recent cerebral trauma
- potentially eligible to thrombolysis
- impaired consciousness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed
Time frame: 18 months
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.
6 secondary outcomes
Evaluate the time of care
Time frame: 18 months
Number of CT and brain MRI requested by the emergency physician in the before / after groups
Time frame: 18 months
Evaluate the usual management of vertigo and diplopia
Time frame: 18 months
Evaluate the rate of new consultations in emergencies
Time frame: 18 months
Rate of new emergency department visits for neurological
Time frame: the month following initial emergency care
Evaluate the irradiation rate
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- Derived from this study: PubMed 35554653Kepka 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabrina GARNIER KEPKA principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Dizziness, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis is established on the positive signs of stroke highlighted on the CT scan or brain MRI according to the examination performed (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.