Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke

NCT ID: NCT06262217

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-11

Study Completion Date

2024-08-01

Brief Summary

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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

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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

Conditions

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Stroke, Acute

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Mobile MRI

Mobile MRI scan

Mobile MRI scanner

Intervention Type DEVICE

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

Interventions

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Mobile MRI scanner

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Glasgow

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keith W Muir, MD

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Locations

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Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Keith W Muir, MD

Role: CONTACT

+44 (0)141 451 5892

Facility Contacts

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Stewart Rodney

Role: primary

0141 451 6879

Other Identifiers

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INGN21ST510

Identifier Type: -

Identifier Source: org_study_id

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