Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke
- Conditions
- Stroke, Acute
- Interventions
- Device: Mobile MRI scanner
- Registration Number
- NCT06262217
- Lead Sponsor
- NHS Greater Glasgow and Clyde
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow & Clyde
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Mobile MRI Mobile MRI scanner Mobile MRI scan
- Primary Outcome Measures
Name Time Method Diagnostic sensitivity and specificity of mobile MRI scanner 1 week In patients with suspected or confirmed acute stroke (including transient ischaemic attack), what is the sensitivity and specificity of scans obtained with a mobile low field MRI scanner compared to routine diagnostic scanning
- Secondary Outcome Measures
Name Time Method Patient Outcomes 3 months Disability at 3 months after stroke using modified rankin scale with higher scores corresponding to worse outcomes
Final Clinical Diagnosis 3 months Final clinical diagnosis
Use of treatments 3 months Use of treatments (acute or to deal with complications of stroke)
Level of confidence in final diagnosis 3 months Level of confidence in final diagnosis on scale of possible, probable or definite
Comparison of MRI abnormalities 1 week Number, size and location of mobile MRI abnormalities compared to routine scanning with MRI or CT (including CT perfusion scans to examine brain blood flow)
Time from arrival at the Emergency Department to scan 2 weeks Time from hospital arrival to scan in acute patients
Trial Locations
- Locations (1)
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom