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RECRUITING
NCT07702968

Low-Field MRI in Stroke Code Patients

Sponsor: Leiden University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2026-04-20

Completion Date

2027-08-01

Last Updated

2026-07-16

Healthy Volunteers

No

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.

Locations (1)

Leiden University Medical Center

Leiden, South Holland, Netherlands