Low-Field MRI in Stroke Code Patients

NCT07702968 | Recruiting FDA Device

• 1 other identifier: NL87809.058.24
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the accuracy and feasibility of a portable low-field MRI (Hyperfine) device in patients presenting to the emergency department with suspected acute stroke. All enrolled patients undergo standard clinical imaging (CT, CT angiography, CT perfusion) and additionally receive a low-field MRI scan. Low-field MRI findings are compared to routine CT imaging and final clinical diagnosis. The study aims to determine whether low-field MRI can reliably detect acute ischemic stroke (including lacunar and large vessel occlusion), hemorrhagic stroke, and stroke mimics in the acute setting. Secondary outcomes include feasibility measures such as scan time, completion rate, patient satisfaction, and adverse events.

Conditions

Acute Stroke; MRI Imaging

Keywords

Acute stroke; Low-field MRI; Hyperfine

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of low-field MRI for acute stroke detection

  Sensitivity, specificity, positive predictive value, and negative predictive value of low-field MRI findings for detecting acute stroke (ischemic or hemorrhagic) and stroke mimics, using final clinical diagnosis at discharge as the reference standard. Low-field MRI images are assessed by a neuroradiologist blinded to CT findings and final diagnosis.

  At time of low-field MRI scan (within 12 hours of symptom onset)

Secondary Outcomes (2)

• Adverse events during low-field MRI scanning

  During low-field MRI scan and up to 30 minutes thereafter

• Patient satisfaction with low-field MRI procedure

  Within 24 hours after low-field MRI scan.

Study Arms (4)

Ischemic stroke - lacunar infarct

Patients with clinical and radiological suspicion of lacunar ischemic stroke (subcortical infarct). These patients often receive additional conventional MRI during routine work-up for radiological confirmation. All patients undergo low-field MRI scanning in addition to routine clinical imaging.

Device: Low-field MRI

Hemorrhagic stroke

Patients with hemorrhagic stroke (intracerebral hemorrhage) demonstrated on non-contrast CT at the emergency department. All patients undergo low-field MRI scanning in addition to routine clinical imaging.

Device: Low-field MRI

Stroke mimic

Patients with non-stroke diagnosis based on clinical judgment and neuro-imaging at the emergency department (e.g., epilepsy, migraine, functional neurological disorder). All patients undergo low-field MRI scanning in addition to routine clinical imaging.

Device: Low-field MRI

Ischemic stroke - proximal vessel occlusion

Patients with ischemic stroke due to proximal vessel occlusion in the anterior circulation (large vessel occlusion, LVO) diagnosed by CT angiography at the emergency department. All patients in this group undergo low-field MRI scanning in addition to routine clinical imaging.

Device: Low-field MRI

Interventions

Low-field MRI DEVICE

Low-field MRI (Hyperfine Swoop, 0.064 Tesla) is performed once, in addition to routine clinical imaging (non-contrast CT, CT angiography, and CT perfusion as clinically indicated). The scan is acquired after routine imaging and after initial treatment decisions, during office hours, with the patient on their ED bed. Scan duration and any interruptions are recorded.

Hemorrhagic stroke; Ischemic stroke - lacunar infarct; Ischemic stroke - proximal vessel occlusion; Stroke mimic

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

Adult patients presenting to the emergency department of a tertiary academic hospital (LUMC) with suspected acute stroke (stroke code activation) within 12 hours of symptom onset. The study population includes patients with ischemic stroke (large vessel occlusion and lacunar), hemorrhagic stroke, and stroke mimics, reflecting real-world acute stroke diagnostics.

You may qualify if:

• Age ≥ 18 years
• Presentation with suspected acute stroke (stroke code activation by ambulance paramedics)
• Symptom onset \< 12 hours prior to presentation
• Admission to the emergency department of the Leiden University Medical Center (LUMC) during office hours
• Undergoing standard-of-care head CT imaging at the emergency department
• Ability to provide informed consent (written or verbal in the acute setting, with deferred written consent if applicable)

You may not qualify if:

• Imminent death
• Severe claustrophobia preventing MRI
• Presence of MRI-incompatible implanted devices (e.g., pacemaker, cochlear implant, insulin pump)
• Known intra-ocular metallic foreign body or intracranial metallic clip/device identified on admission CT
• Pregnancy
• Acute life-threatening or disabling condition requiring immediate intervention that precludes study procedures
• Any study-related delay that could interfere with time-critical stroke treatments (intravenous thrombolysis or endovascular thrombectomy)

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

RECRUITING

Related Publications (2)

• 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

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Nyika Kruyt, MD, PhD

CONTACT

+31 71 526 9111; n.d.kruyt@lumc.nl

Robert Croese

CONTACT

r.j.i.croese@lumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurologist

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 14, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)