Point-of-care Low-field MRI in Acute Stroke

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.

NCT Number	NCT05816213
Lead Sponsor	University of L'Aquila
Conditions	Stroke, Ischemic Stroke, Hemorrhagic Stroke, Magnetic Resonance Imaging
Enrollment	300 participants
Start Date	2025-02-01
Primary Completion	2026-09-01 (estimated)
Study Completion	2026-11-01 (estimated)
Updated on ClinicalTrials.gov	2024-12-09