Point-of-care Low-field MRI in Acute Stroke
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of L'Aquila
About this trial
Consecutive patients accessing the emergency department with suspected stroke dispatch will be recruited at 3 study units: 1) ASL Abruzzo 1, hospitals of L'Aquila and Avezzano; 2) ASL Abruzzo 2, hospital of Chieti; 3) IRCCS Humanitas Research Hospital of Milan. Anonymized clinical and low-field (LF) MRI data as well as conventional neuroimaging data will be independently assessed by external units (Università Politecnica delle Marche and Policlinico di Messina, respectively). Both units will independently adjudicate the best treatment option, while the latter will also provide historical MRI data of stroke patients to develop artificial intelligence algorithms facilitating LF-MRI images interpretation (Libera Università di Bolzano). Agreement with conventional neuroimaging will be evaluated at different time points (hyperacute, acute -24 h, subacute -72 h, discharge, chronic -4 weeks). Further investigations will include feasibility study to develop an ambulance (mobile stroke unit) equipped with LF-MRI and cost-effectiveness analysis of LF-MRI. This trial will provide necessary data to validate the use of LF-MRI in the acute stroke care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
symptoms suggestive of acute stroke (acute onset of a focal neurological deficit which can be referred to the involvement of a specific CNS region);
stroke onset <24 h since when the patient was last known healthy;
written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired or aphasic).
Disqualifiers
symptoms not indicative of acute stroke (e.g. syncope, tonic or clonic activity, dizziness or wooziness alone, confusion and amnesia alone, subacute or chronic development of a focal neurological deficit);
inability to undergo LF-MRI due to critically impaired vital functions (e.g. hemodynamically unstable patients, need of immediate life-saving maneuvers);
implanted ferromagnetic devices potentially interfering with LF-MRI (e.g. cochlear implants);
impossibility to achieve written informed consent.
Trial population
The study will include consecutive patients admitted to the Emergency Department (ED) of recruiting centers with a dispatch of suspected stroke. Dispatches will be provided by Emergency Medical Services or ED physicians according to local acute stroke management protocols and current clinical practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Portable low-field MRI
DeviceThree FDA-approved low-field (LF) portable MRI commercialized by Hyperfine Research Inc. (www.hyperfine.io) will be employed. Patients will undergo LF-MRI in the CT suite during the downtime of preparation which usually occurs after urgent imaging in the CT suite (mean time, as calculated basing on the current door to imaging time: \~20-25 minutes), thus not delaying the conventional diagnostic processes and treatment administration. LF-MRI will be also repeated by the study staff at predefined time-points: 24 h, 72 h, at the discharge and 4 weeks after the event. A prespecified acquisition of Fast-Spin Echo (Fast-SE) essential stroke sequences will be performed, starting with diffusion weighted imaging (DWI) + apparent diffusion coefficient (ADC) mapping and fluid attenuated inversion recovery (FLAIR).
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Accuracy of LF-MRI in the diagnosis of stroke in the acute phase.
To evaluate the sensitivity and specificity with respect to final adjudication of the event.
Time frame
3 yearsSecondary outcomes
1
Rate of detection of lesions at LF-MRI vs. non-contrast CT
to compare the accuracy of LF-MRI scans with the accuracy of routinely performed head CT scans for infarcts and hemorrhage detection (endpoint: agreement between LF-MRI and head CT scans in detecting infarcts and hemorrhages)
Time frame
3 years2
Rate of detection of lesions at LF-MRI vs. high-field MRI
to compare the accuracy of LF-MRI scans with the accuracy of routinely performed brain HF-MRI scans for infarcts and hemorrhage detection (endpoint: agreement between LF-MRI and HF-MRI scans in detecting infarcts and hemorrhages)
Time frame
3 years3
Accuracy of LF-MRI as a tool to guide the treatment decision process
Evaluate the impact of LF-MRI on the clinical decision-making process related to revascularization treatments for ischemic stroke, as compared to the conventional acute stroke diagnostic (endpoint: agreement between the best treatment option based upon LF-MRI and the best treatment option based upon conventional imaging). Acute stroke diagnostics will consist for some patients in brain CT and high-field MRI for others
Time frame
3 years4
Accuracy of LF-MRI in identifying stroke mimics
To assess whether LF-MRI may improve the detection of patients with stroke mimics in the acute phase and the discrimination with acute ischemic stroke (endpoint: agreement between LF-MRI and conventional imaging in detecting stroke mimics)
Time frame
3 yearsSponsors and contacts
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Source ClinicalTrials.gov
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