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Low-Field MRI in Stroke Code Patients

NCT07702968 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-07-16

No results posted yet for this study

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.

Conditions

  • Acute Stroke
  • MRI Imaging

Interventions

DEVICE

Low-field MRI

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.

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-20
Primary Completion
2027-04-01
Completion
2027-08-01
FDA Device
Yes

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07702968 on ClinicalTrials.gov