Low-Field MRI in Stroke Code Patients

Leiden University Medical Center80 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Acute Stroke MRI Imaging

Interventions

Low-field MRIDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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) Exclusion Criteria: * 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)

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Adverse events during low-field MRI scanning

Number and type of adverse events (AEs) and serious adverse events (SAEs) occurring during the low-field MRI scanning procedure or within 30 minutes after completion.

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

Patient satisfaction with low-field MRI procedure

Patient-reported satisfaction with the low-field MRI scanning experience, assessed using a structured questionnaire or verbal interview.

Time frame: Within 24 hours after low-field MRI scan.