Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During low-field MRI scan and up to 30 minutes thereafter |
| Patient satisfaction with low-field MRI procedure |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nyika Kruyt, MD, PhD | Contact | +31 71 526 9111 | n.d.kruyt@lumc.nl | |
| Robert Croese | Contact | r.j.i.croese@lumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Center | Recruiting | Leiden | South Holland | 2333ZA | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34433813 | 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. | |
| 32897296 |
Not provided
Not provided
Due to the limited sample size, the single-centre design, and privacy considerations under GDPR, there is no plan to share individual participant data. Aggregate results will be published in peer-reviewed journals and presented at scientific meetings.
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2025 | Jul 3, 2026 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
|
Patient-reported satisfaction with the low-field MRI scanning experience, assessed using a structured questionnaire or verbal interview. |
| Within 24 hours after low-field MRI scan. |
| 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |