Testing a Portable Low-Field MRI Scanner in Acute Stroke Patients
Compares a portable low-field MRI scanner with standard brain imaging in adults with suspected stroke.
Plain-language title generated from the registry record
Registry title: Point-of-care Low-field MRI in Acute Stroke
Key facts
- Where
- Avezzano, Chieti, L’Aquila, and Milan, ItalySee the 4 sites
Where in Italy
- SS Filippo e Nicola Hospital of AvezzanoAvezzano, ItalyNo longer taking part
- SS Annunziata Hospital of ChietiChieti, ItalyNo longer taking part
- S Salvatore Hospital of L'AquilaL’Aquila, ItalyNo longer taking part
- IRCCS Humanitas Research Hospital of RozzanoMilan, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of L'Aquila
- Trial code
- NCT05816213
- Record updated
- 9 December 2024
- Original description
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.Read full original descriptionShow less
Point-of-care Low-field Magnetic Resonance Imaging in Acute Stroke (POCS) Study
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.
Inclusion: 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).
Exclusion: implanted ferromagnetic devices potentially interfering with LF-MRI (e.g. cochlear implants); 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); impossibility to achieve written informed consent.