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Point-Of-Care low-field MRI in acute Stroke (POCS): protocol for a multicentric prospective open-label study evaluating diagnostic accuracy

Foschi, Matteo ; Galante, Angelo ; Ornello, Raffaele ; Necozione, Stefano ; Marini, Carmine ; Muselli, Mario ; Achard, Paola Olimpia ; Fratocchi, Luciano ; Vinci, Sergio Lucio ; Cavallaro, Marco ; Silvestrini, Mauro ; Polonara, Gabriele ; Marcheselli, Simona ; Straffi, Laura ; Colasurdo, Marco ; Sorrentino, Luca ; Franconi, Enrico ; Alecci, Marcello ; Caulo, Massimo ; Sacco, Simona

BMJ open, 2024-01, Vol.14 (1), p.e075614-e075614 [Periódico revisado por pares]

England: British Medical Journal Publishing Group

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Título:
Point-Of-Care low-field MRI in acute Stroke (POCS): protocol for a multicentric prospective open-label study evaluating diagnostic accuracy
Autor: Foschi, Matteo ; Galante, Angelo ; Ornello, Raffaele ; Necozione, Stefano ; Marini, Carmine ; Muselli, Mario ; Achard, Paola Olimpia ; Fratocchi, Luciano ; Vinci, Sergio Lucio ; Cavallaro, Marco ; Silvestrini, Mauro ; Polonara, Gabriele ; Marcheselli, Simona ; Straffi, Laura ; Colasurdo, Marco ; Sorrentino, Luca ; Franconi, Enrico ; Alecci, Marcello ; Caulo, Massimo ; Sacco, Simona
Assuntos: Accuracy ; Artificial Intelligence ; Complex patients ; Cost analysis ; Diagnostic Imaging ; Hemorrhage ; Humans ; Ischemia ; Magnetic Resonance Imaging ; Medical diagnosis ; Medical imaging ; Multicenter Studies as Topic ; Neuroimaging ; Neurology ; Performance evaluation ; Point-of-Care Systems ; Prospective Studies ; Research Design ; Stroke ; Stroke - diagnostic imaging ; Stroke - therapy ; Traumatic brain injury
É parte de: BMJ open, 2024-01, Vol.14 (1), p.e075614-e075614
Notas: Protocol
ObjectType-Article-1
SourceType-Scholarly Journals-1
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Descrição: IntroductionFast and accurate diagnosis of acute stroke is crucial to timely initiate reperfusion therapies. Conventional high-field (HF) MRI yields the highest accuracy in discriminating early ischaemia from haemorrhages and mimics. Rapid access to HF-MRI is often limited by contraindications or unavailability. Low-field (LF) MRI (<0.5T) can detect several types of brain injury, including ischaemic and haemorrhagic stroke. Implementing LF-MRI in acute stroke care may offer several advantages, including extended applicability, increased safety, faster administration, reduced staffing and costs. This multicentric prospective open-label trial aims to evaluate the diagnostic accuracy of LF-MRI, as a tool to guide treatment decision in acute stroke.Methods and analysisConsecutive patients accessing the emergency department with suspected stroke dispatch will be recruited at three Italian study units: Azienda Sanitaria Locale (ASL) Abruzzo 1 and 2, Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Humanitas Research Hospital. The estimated sample size is 300 patients. Anonymised clinical and LF-MRI data, along with conventional neuroimaging data, will be independently assessed by two external units: Marche Polytechnic University and ‘G. Martino’ Polyclinic University Hospital. Both units will independently adjudicate the best treatment option, while the latter will provide historical HF-MRI data to develop artificial intelligence algorithms for LF-MRI images interpretation (Free University of Bozen-Bolzano). Agreement with conventional neuroimaging will be evaluated at different time points: hyperacute, acute (24 hours), subacute (72 hours), at discharge and chronic (4 weeks). Further investigations will include feasibility study to develop a mobile stroke unit equipped with LF-MRI and cost-effectiveness analysis. This trial will provide necessary data to validate the use of LF-MRI in acute stroke care.Ethics and disseminationThe study was approved by the Research Ethics Committee of the Abruzzo Region (CEtRA) on 11 May 2023 (approval code: richyvgrg). Results will be disseminated in peer-reviewed journals and presented in academic conferences.Trial registration numberNCT05816213; Pre-Results.
Editor: England: British Medical Journal Publishing Group
Idioma: Inglês

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Point-Of-Care low-field MRI in acute Stroke (POCS): protocol for a multicentric prospective open-label study evaluating diagnostic accuracy

England: British Medical Journal Publishing Group

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