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

NCT05816213 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: T2-AN-13
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Magnetic Resonance Imaging

Keywords

Stroke; Diagnosis; Low-field MRI; Stroke treatment

Outcome Measures

Primary Outcomes (1)

• Accuracy of LF-MRI in the diagnosis of stroke in the acute phase.

  To evaluate the sensitivity and specificity with respect to final adjudication of the event.

  3 years

Secondary Outcomes (5)

• Rate of detection of lesions at LF-MRI vs. non-contrast CT

  3 years

• Rate of detection of lesions at LF-MRI vs. high-field MRI

  3 years

• Accuracy of LF-MRI as a tool to guide the treatment decision process

  3 years

• Accuracy of LF-MRI in identifying stroke mimics

  3 years

• Accuracy of LF-MRI at different post-stroke time points

  3 years

Interventions

Portable low-field MRI DEVICE

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include consecutive patients admitted to the Emergency Department (ED) of recruiting centers with a dispatch of suspected stroke. Dispatches will be provided by Emergency Medical Services or ED physicians according to local acute stroke management protocols and current clinical practice.

You may qualify if:

• 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).

You may not qualify if:

• 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);
• implanted ferromagnetic devices potentially interfering with LF-MRI (e.g. cochlear implants);
• impossibility to achieve written informed consent.

Sponsors & Collaborators

• University of L'Aquila: lead

Study Sites (4)

SS Filippo e Nicola Hospital of Avezzano

Avezzano, Abruzzo, 67051, Italy

Location

SS Annunziata Hospital of Chieti

Chieti, Abruzzo, 66100, Italy

Location

S Salvatore Hospital of L'Aquila

L’Aquila, Abruzzo, 67100, Italy

Location

IRCCS Humanitas Research Hospital of Rozzano

Milan, Lombardy, 20089, Italy

Location

Related Publications (4)

• Okorie CK, Ogbole GI, Owolabi MO, Ogun O, Adeyinka A, Ogunniyi A. Role of Diffusion-weighted Imaging in Acute Stroke Management using Low-field Magnetic Resonance Imaging in Resource-limited Settings. West Afr J Radiol. 2015 Jul-Dec;22(2):61-66. doi: 10.4103/1115-3474.162168. Epub 2015 Nov 16.

  PMID: 26709342 BACKGROUND

• Mazurek MH, Cahn BA, Yuen MM, Prabhat AM, Chavva IR, Shah JT, Crawford AL, Welch EB, Rothberg J, Sacolick L, Poole M, Wira C, Matouk CC, Ward A, Timario N, Leasure A, Beekman R, Peng TJ, Witsch J, Antonios JP, Falcone GJ, Gobeske KT, Petersen N, Schindler J, Sansing L, Gilmore EJ, Hwang DY, Kim JA, Malhotra A, Sze G, Rosen MS, Kimberly WT, Sheth KN. Portable, bedside, low-field magnetic resonance imaging for evaluation of intracerebral hemorrhage. Nat Commun. 2021 Aug 25;12(1):5119. doi: 10.1038/s41467-021-25441-6.

  PMID: 34433813 BACKGROUND

• Sheth KN, Mazurek MH, Yuen MM, Cahn BA, Shah JT, Ward A, Kim JA, Gilmore EJ, Falcone GJ, Petersen N, Gobeske KT, Kaddouh F, Hwang DY, Schindler J, Sansing L, Matouk C, Rothberg J, Sze G, Siner J, Rosen MS, Spudich S, Kimberly WT. Assessment of Brain Injury Using Portable, Low-Field Magnetic Resonance Imaging at the Bedside of Critically Ill Patients. JAMA Neurol. 2020 Sep 8;78(1):41-7. doi: 10.1001/jamaneurol.2020.3263. Online ahead of print.

  PMID: 32897296 BACKGROUND

• Foschi M, Galante A, Ornello R, Necozione S, Marini C, Muselli M, Achard PO, Fratocchi L, Vinci SL, Cavallaro M, Silvestrini M, Polonara G, Marcheselli S, Straffi L, Colasurdo M, Sorrentino L, Franconi E, Alecci M, Caulo M, Sacco S. Point-Of-Care low-field MRI in acute Stroke (POCS): protocol for a multicentric prospective open-label study evaluating diagnostic accuracy. BMJ Open. 2024 Jan 31;14(1):e075614. doi: 10.1136/bmjopen-2023-075614.

  PMID: 38296269 DERIVED

MeSH Terms

Conditions

Stroke; Ischemic Stroke; Hemorrhagic Stroke; Disease

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Simona Sacco, MD

CONTACT

+390863499734; simona.sacco@univaq.it

Matteo Foschi, MD

CONTACT

+393478929126; matteo.foschi@graduate.univaq.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 18, 2023
• Study Start: February 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)