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Recruiting NCT07702968

Low-Field MRI in Stroke Code Patients

— Observational Acute Stroke MRI Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Low-field MRI.
Who it may be relevant to
Registry conditions: Acute Stroke, MRI Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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.

Primary outcome measures

  • 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)]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Netherlands · 1 center
  • Leiden University Medical Center — Leiden

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 PMID 34433813
  • Sheth 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: 10.100 PMID 32897296

Identifiers

NCT: NCT07702968 · NL87809.058.24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗