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NCT Number: NCT07702968

Low-Field MRI in Stroke Code Patients

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders MRI Imaging Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Leiden University Medical Center

Leiden, South Holland, 2333ZA, Netherlands

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Adverse events during low-field MRI scanning

    Time frame: 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.

  2. Patient satisfaction with low-field MRI procedure

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nyika Kruyt, MD, PhD

CONTACT

[email protected]

+31 71 526 9111

Robert Croese

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Leiden University Medical Center

Other

Registry information

Official study title

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

Acronym: LFMIS

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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