[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100501973":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":23,"responsibleParty":89,"collaborators":7,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":7,"enrollmentInfo":103,"targetDuration":7,"studyType":106,"phases":7,"briefSummary":107,"conditions":108,"keywords":113,"overallStatus":117,"whyStopped":7,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"University of L'Aquila","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DEVICE","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.\n\nA 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).",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Simona Sacco, MD","CONTACT","+390863499734","simona.sacco@univaq.it",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":22},"Matteo Foschi, MD","+393478929126","matteo.foschi@graduate.univaq.it",[24,46,60,74],{"facility":25,"status":7,"city":26,"state":27,"zip":28,"country":29,"countryCode":30,"cosmosGeoPoint":31,"geoPoint":36,"contacts":37},"SS Filippo e Nicola Hospital of Avezzano","Avezzano","Abruzzo","67051","Italy","IT",{"type":32,"coordinates":33},"Point",[34,35],13.42641,42.02896,{"lat":35,"lon":34},[38,40,42,44],{"name":15,"role":16,"phone":39,"phoneExt":7,"email":18},"+390862433561 - +390863499764",{"name":20,"role":16,"phone":41,"phoneExt":7,"email":22},"+393478029126",{"name":20,"role":43,"phone":7,"phoneExt":7,"email":7},"SUB_INVESTIGATOR",{"name":45,"role":43,"phone":7,"phoneExt":7,"email":7},"Raffaele Ornello, MD",{"facility":47,"status":7,"city":48,"state":27,"zip":49,"country":29,"countryCode":30,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"SS Annunziata Hospital of Chieti","Chieti","66100",{"type":32,"coordinates":51},[52,53],14.16494,42.34827,{"lat":53,"lon":52},[56],{"name":57,"role":16,"phone":58,"phoneExt":7,"email":59},"Massimo Caulo, MD,PhD","+3908713556911","massimo.caulo@unich.it",{"facility":61,"status":7,"city":62,"state":27,"zip":63,"country":29,"countryCode":30,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"S Salvatore Hospital of L'Aquila","L’Aquila","67100",{"type":32,"coordinates":65},[66,67],13.39954,42.35055,{"lat":67,"lon":66},[70],{"name":71,"role":16,"phone":72,"phoneExt":7,"email":73},"Carmine Marini, MD, PhD","+39 0862434743","carmine.marini@univaq.it",{"facility":75,"status":7,"city":76,"state":77,"zip":78,"country":29,"countryCode":30,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"IRCCS Humanitas Research Hospital of Rozzano","Milan","Lombardy","20089",{"type":32,"coordinates":80},[81,82],9.18951,45.46427,{"lat":82,"lon":81},[85],{"name":86,"role":16,"phone":87,"phoneExt":7,"email":88},"Simona Marcheselli, MD","+39 02 8224 8224","simona.marcheselli@humanitas.it",{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"PRINCIPAL_INVESTIGATOR","Simona Sacco","Full Professor of Neurology","100501973","point-of-care-low-field-mri-in-acute-stroke-100501973",false,"NCT05816213","Point-of-care Low-field MRI in Acute Stroke","Point-of-care Low-field Magnetic Resonance Imaging in Acute Stroke (POCS) Study","POCS","Inclusion Criteria:\n\n1. symptoms suggestive of acute stroke (acute onset of a focal neurological deficit which can be referred to the involvement of a specific CNS region);\n2. stroke onset \\\u003C24 h since when the patient was last known healthy;\n3. written informed consent provided by the patient himself or by proxy (for unconscious patients, cognitively impaired or aphasic).\n\nExclusion Criteria:\n\n1. 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);\n2. inability to undergo LF-MRI due to critically impaired vital functions (e.g. hemodynamically unstable patients, need of immediate life-saving maneuvers);\n3. implanted ferromagnetic devices potentially interfering with LF-MRI (e.g. cochlear implants);\n4. impossibility to achieve written informed consent.","ALL","18 Years",{"count":104,"type":105},300,"ESTIMATED","OBSERVATIONAL","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.",[109,110,111,112],"Stroke","Ischemic Stroke","Hemorrhagic Stroke","Magnetic Resonance Imaging",[109,114,115,116],"Diagnosis","Low-field MRI","Stroke treatment","NOT_YET_RECRUITING","2024-12-04",{"date":120,"type":121},"2024-12-09","ACTUAL",{"date":123,"type":105},"2025-02-01",{"date":125,"type":105},"2026-11-01",{"name":5,"class":6},4]