Clinical Research Directory
Browse clinical research sites, groups, and studies.
Point-of-care Low-field MRI in Acute Stroke
Sponsor: University of L'Aquila
Summary
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.
Official title: Point-of-care Low-field Magnetic Resonance Imaging in Acute Stroke (POCS) Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2025-02-01
Completion Date
2026-11-01
Last Updated
2024-12-09
Healthy Volunteers
No
Interventions
Portable low-field MRI
Three 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).
Locations (4)
SS Filippo e Nicola Hospital of Avezzano
Avezzano, Abruzzo, Italy
SS Annunziata Hospital of Chieti
Chieti, Abruzzo, Italy
S Salvatore Hospital of L'Aquila
L’Aquila, Abruzzo, Italy
IRCCS Humanitas Research Hospital of Rozzano
Milan, Lombardy, Italy