Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke (MIRACLES)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke, Acute
• Intervention / Treatment: Device: Mobile MRI scanner

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Keith W Muir, MD; Phone Number: +44 (0)141 451 5892; Email: keith.muir@glasgow.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Recruiting
    • Queen Elizabeth University Hospital
    • Contact: Stewart Rodney; Phone Number: 0141 451 6879; Email: stewart.rodney@glasgow.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mobile MRI; Mobile MRI scan	Device: Mobile MRI scanner; Use of mobile MRI scanner in patients with suspected or confirmed acute stroke (including Transient Ischaemic attacks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Final Clinical Diagnosis	Final clinical diagnosis and level of confidence in diagnosis	3 months
Final Clinical Diagnosis	Final clinical diagnosis	3 months
Time from arrival at the Emergency Department to scan	Time from hospital arrival to scan in acute patients	2 weeks
Use of treatments	Use of treatments (acute or to deal with complications of stroke)	3 months
Patient Outcomes	Disability at 3 months after stroke using modified rankin scale with higher scores corresponding to worse outcomes	3 months
Level of confidence in final diagnosis	Level of confidence in final diagnosis on scale of possible, probable or definite	3 months

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Glasgow
• Investigators: Principal Investigator: Keith W Muir, MD, University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2023
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: INGN21ST510

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes