Acute Stroke, MRI Imaging
Conditions
Keywords
Acute stroke, Low-field MRI, Hyperfine
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.
Interventions
DEVICELow-field MRI
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.
Sponsors
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of low-field MRI for acute stroke detection | At time of low-field MRI scan (within 12 hours of symptom onset) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events during low-field MRI scanning | During low-field MRI scan and up to 30 minutes thereafter | 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. |
| Patient satisfaction with low-field MRI procedure | Within 24 hours after low-field MRI scan. | Patient-reported satisfaction with the low-field MRI scanning experience, assessed using a structured questionnaire or verbal interview. |
Countries
Netherlands
Contacts
CONTACTNyika Kruyt, MD, PhD
CONTACTRobert Croese
Outcome results
None listed