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Testing a portable low-field MRI scanner in people with suspected stroke

Checks how well a portable MRI scanner works in suspected stroke in emergency patients.

Plain-language title generated from the registry record
Registry title: Low-Field MRI in Stroke Code Patients

Key facts

Where
Leiden, NetherlandsSee the site

Where in Netherlands

  • Leiden University Medical CenterLeiden, NetherlandsTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Leiden University Medical Center
Trial code
NCT07702968
Record updated
16 July 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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: Presence of MRI-incompatible implanted devices (e.g., pacemaker, cochlear implant, insulin pump); 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); Imminent death; Severe claustrophobia preventing MRI; Known intra-ocular metallic foreign body or intracranial metallic clip/device identified on admission CT; Pregnancy.

ClinicalTrials.gov NCT07702968