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
Qualifiers
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 design
Treatments tested in this trial
- Portable low-field MRI
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov