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Validation of Low Field MRI in Patients With Stroke Symptoms Less Than 12 Hours

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Nyika Kruyt, MD, PhD
n.d.kruyt@lumc.nl
+31 71 526 9111
Backup
Robert Croese
r.j.i.croese@lumc.nl
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2027-08-01
Participants
Target number of participants: 80
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov