Stroke, AcuteMIRACLESNCT06262217
Mobile MRI for Immediate Radiological Acute Cerebral Lesion Evaluation in Stroke
An observational study of Stroke, Acute, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Acute
- What is being tested?
- Mobile MRI scanner
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Nov 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA
Who may be able to join
- 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
Who cannot join
- Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow \& Clyde
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Queen Elizabeth University Hospital
Glasgow
Stewart Rodney, 0141 451 6879, stewart.rodney@glasgow.ac.uk
About this study
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
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.
Read the detailed description
The study will investigate mobile MRI for immediate radiological acute cerebral lesion evaluation in Stroke. The objectives are:
- 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
- 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.
- Among patients with confirmed acute ischaemic stroke, to compare the volume of DWI lesion on mobile MRI with the core volume on CTP
- 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
- In all groups, to evaluate the tolerability and ease of use of the mobile MRI scanner, and to rate image quality
- Conditions
- Stroke, Acute
- Being tested
- Mobile MRI scanner
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile MRI scannerDevice
Use of mobile MRI scanner in patients with suspected or confirmed acute stroke (including Transient Ischaemic attacks)
| Study group | Role | What they receive |
|---|---|---|
| Mobile MRI | Mobile MRI scan Receives: Device: Mobile MRI scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Secondary outcomes (7)
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)
Measured: 1 week
Final Clinical Diagnosis
Final clinical diagnosis and level of confidence in diagnosis
Measured: 3 months
Final Clinical Diagnosis
Final clinical diagnosis
Measured: 3 months
Time from arrival at the Emergency Department to scan
Time from hospital arrival to scan in acute patients
Measured: 2 weeks
Use of treatments
Use of treatments (acute or to deal with complications of stroke)
Measured: 3 months
Patient Outcomes
Disability at 3 months after stroke using modified rankin scale with higher scores corresponding to worse outcomes
Measured: 3 months
Level of confidence in final diagnosis
Level of confidence in final diagnosis on scale of possible, probable or definite
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start11 Nov 2023
- Primary completion31 May 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
- Investigators
- Keith W Muir, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262217
- Sponsor's protocol ID
- INGN21ST510
- Acronym
- MIRACLES
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2023
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06262217
- Acronym / sponsor ID
- MIRACLES / INGN21ST510
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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.
- Among patients with confirmed acute ischaemic stroke, to compare the volume of DWI lesion on mobile MRI with the core volume on CTP
- 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
- In all groups, to evaluate the tolerability and ease of use of the mobile MRI scanner, and to rate image quality
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile MRI | – | Device: Mobile MRI scannerMobile MRI scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically suspected stroke or transient ischaemic attack, or confirmed clinical diagnosis of stroke or TIA
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Contraindications to MRI brain scan as per standard MRI checklist for NHS Greater Glasgow \& Clyde
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile MRI scannerUse of mobile MRI scanner in patients with suspected or confirmed acute stroke (including Transient Ischaemic attacks) | Device | Mobile MRI |
Primary outcome
Diagnostic sensitivity and specificity of mobile MRI scanner
Time frame: 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
7 secondary outcomes
Comparison of MRI abnormalities
Time frame: 1 week
Final Clinical Diagnosis
Time frame: 3 months
Final Clinical Diagnosis
Time frame: 3 months
Time from arrival at the Emergency Department to scan
Time frame: 2 weeks
Use of treatments
Time frame: 3 months
Patient Outcomes
Time frame: 3 months
Level of confidence in final diagnosis
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Keith W Muir, MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Keith W Muir, MD (+44 (0)141 451 5892, keith.muir@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity and specificity of mobile MRI scanner (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.