Clinical trial NCT06262217: Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke
Official title: Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke: Investigating the Use of a Small Mobile MRI Scanner to Aid Investigation of Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2024-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA

Brief summary: This prospective observational study will evaluate the potential value of mobile MRI in patients with suspected or proven acute stroke and Transient Ischemic Attack (TIA), undertaking additional imaging in the emergency department, acute stroke unit, or outpatient settings, and comparing diagnostic accuracy, Diffusion-weighted imaging (DWI) lesion volume and detection of complications (brain swelling or haemorrhagic transformation). Information on ease of use, tolerability and image quality will also be gathered.

Detailed description: The study will investigate mobile MRI for immediate radiological acute cerebral lesion evaluation in Stroke. The objectives are:

1. Among patients with possible acute minor stroke or TIA, to compare the detection rate of acute DWI lesions on mobile MRI scan with routine imaging, describe number and distribution of lesions, and describe the intervals between mobile MRI and routine diagnostic scan, and time to final clinical diagnosis
2. Among patients with acute stroke of uncertain onset time, to compare the presence of DWI-Fluid attenuated inversion recovery (FLAIR) mismatch pattern on mobile MRI with CT perfusion (CTP) mismatch.
3. Among patients with confirmed acute ischaemic stroke, to compare the volume of DWI lesion on mobile MRI with the core volume on CTP
4. Among patients with established stroke post-thrombolysis or thrombectomy, to compare the incidence of brain swelling and haemorrhagic transformation on mobile MRI with routine imaging
5. In all groups, to evaluate the tolerability and ease of use of the mobile MRI scanner, and to rate image quality

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female \> or = 18 years of age
* Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA
* Consent of patient or legal representative

Exclusion Criteria:

* Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow \& Clyde

Primary outcomes:
measure: Diagnostic sensitivity and specificity of mobile MRI scanner
timeFrame: 1 week
Secondary outcomes:
measure: Comparison of MRI abnormalities
timeFrame: 1 week
measure: Final Clinical Diagnosis
timeFrame: 3 months
measure: Final Clinical Diagnosis
timeFrame: 3 months
measure: Time from arrival at the Emergency Department to scan
timeFrame: 2 weeks
measure: Use of treatments
timeFrame: 3 months
measure: Patient Outcomes
timeFrame: 3 months
measure: Level of confidence in final diagnosis
timeFrame: 3 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: University of Glasgow
name: Keith W Muir, MD
role: PRINCIPAL_INVESTIGATOR
References: