Low-Field MRI in Stroke Code Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLeiden University Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Low-field MRI
DeviceLow-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.
Treatment groups
80 Participants
are divided into 4 treatment groupsGroup A: Ischemic stroke - lacunar infarct1 intervention
Group B: Hemorrhagic stroke1 intervention
Group C: Stroke mimic1 intervention
Group D: Ischemic stroke - proximal vessel occlusion1 intervention
Trial outcomes
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.
Time frame
At time of low-field MRI scan (within 12 hours of symptom onset)Secondary outcomes
1
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 thereafter2
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.Sponsors and contacts
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Source ClinicalTrials.gov