Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke

Stroke, Acute Clinical Trial

— MIRACLES  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06262217
• Other study ID #: INGN21ST510
• Status: Recruiting
• Start date: November 11, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: February 2024
• Source: NHS Greater Glasgow and Clyde
• Contact: Keith W Muir, MD
• Phone: +44 (0)141 451 5892
• Email: keith.muir[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 1, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Device:
• Mobile MRI scanner
Use of mobile MRI scanner in patients with suspected or confirmed acute stroke (including Transient Ischaemic attacks)

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic sensitivity and specificity of mobile MRI scanner	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	1 week
Secondary	Comparison of MRI abnormalities	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)	1 week
Secondary	Final Clinical Diagnosis	Final clinical diagnosis and level of confidence in diagnosis	3 months
Secondary	Final Clinical Diagnosis	Final clinical diagnosis	3 months
Secondary	Time from arrival at the Emergency Department to scan	Time from hospital arrival to scan in acute patients	2 weeks
Secondary	Use of treatments	Use of treatments (acute or to deal with complications of stroke)	3 months
Secondary	Patient Outcomes	Disability at 3 months after stroke using modified rankin scale with higher scores corresponding to worse outcomes	3 months
Secondary	Level of confidence in final diagnosis	Level of confidence in final diagnosis on scale of possible, probable or definite	3 months