Acute StrokeLFMISNCT07702968
Low-Field MRI in Stroke Code Patients
An observational study of Acute Stroke and MRI Imaging, run by Leiden University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke, MRI Imaging
- What is being tested?
- Low-field MRI
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Apr 2026to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Croese contact
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333ZA
About this study
Official title: Validation of Low Field MRI in Patients With Stroke Symptoms Less Than 12 Hours
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
- Being tested
- Low-field MRI
- Keywords
- Acute stroke, Low-field MRI, Hyperfine
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Low-field MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At time of low-field MRI scan (within 12 hours of symptom onset)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Within 24 hours after low-field MRI scan.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start20 Apr 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nyika D. Kruyt, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07702968
- Sponsor's protocol ID
- NL87809.058.24
- Acronym
- LFMIS
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34433813Sheth 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.
PubMed 32897296
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Low Field MRI in Patients With Stroke Symptoms Less Than 12 Hours
- ClinicalTrials.gov ID
- NCT07702968
- Acronym / sponsor ID
- LFMIS / NL87809.058.24
- Conditions
- Acute Stroke, MRI Imaging
- Keywords
- Acute stroke, Low-field MRI, Hyperfine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ischemic stroke - lacunar infarct | – | Device: Low-field MRIPatients 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 | – | Device: Low-field MRIPatients 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 | – | Device: Low-field MRIPatients 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 | – | Device: Low-field MRIPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-field MRILow-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. | Device | Hemorrhagic stroke, Ischemic stroke - lacunar infarct, Ischemic stroke - proximal vessel occlusion, Stroke mimic |
Primary outcome
Diagnostic accuracy of low-field MRI for acute stroke detection
Time frame: 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.
2 secondary outcomes
Adverse events during low-field MRI scanning
Time frame: During low-field MRI scan and up to 30 minutes thereafter
Patient satisfaction with low-field MRI procedure
Time frame: Within 24 hours after low-field MRI scan.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Background: PubMed 34433813Mazurek 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.
- Background: PubMed 32897296Sheth 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Croese contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke and MRI Imaging, run by Leiden University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nyika Kruyt, MD, PhD (+31 71 526 9111, n.d.kruyt@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of low-field MRI for acute stroke detection (time frame: At time of low-field MRI scan (within 12 hours of symptom onset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07702968, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.