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Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients

ConditionStroke Acute
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Aberdeen

About this trial

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can show changes in the brain within the first day of a stroke due to a blocked blood vessel or bleeding in the brain. The main question it aims to answer is:

• Can FCI identify brain tissue that might recover within the first few hours after a stroke begins?

Participants will undergo a standard MRI scan and an FCI scan, as soon as possible after hospital admission.

Participants who have had a blocked blood vessel will also provide a blood sample and will have a follow up visit at 30 days for repeat of both scans and providing another blood sample.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute stroke (<24 hours from symptom onset).

NIHSS ≥4 and <25 with cortical involvement and/or large vessel occlusion on baseline imaging.

Able to undergo 3T and FCI MRI <24h of onset.

With or without thrombolysis.

Disqualifiers

Contraindications to MRI.

Medically unstable.

Unable to comprehend or comply with instructions regarding scanning

Prior mRS of >3.

Trial population

Participants with acute stroke admitted to Aberdeen Royal Infirmary.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 3T MRI research scan

    Other intervention

    Baseline MRI scan

  • Field-Cycling Imaging research scan

    Other intervention

    Baseline FCI scan

  • Follow up 3T MRI research scan

    Other intervention

    Day 30 3T MRI scan

  • Follow up Field-Cycling Imaging research scan

    Other intervention

    Day 30 FCI scan

  • Blood samples for clotting experiments in vitro

    Other intervention

    Thrombi from whole blood from ischaemic stroke patients will be formed and examined using bench top nuclear magnetic resonance (NMR) assays. At baseline and 30 days after stroke onset.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Ischaemic stroke5 interventions
Group B: Haemorrhagic stroke2 interventions

Trial outcomes

Primary outcomes

1

Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline

Receiver operator curves (ROC) curves comparing extent of at-risk tissue/infarct core obtained from FCI dispersion maps and from 3T MRI modalities at baseline at stroke onset.

Time frame
Baseline at stroke onset

Secondary outcomes

1

Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline

Receiver operator curves (ROC) curves comparing extent of haemorrhagic volume obtained from FCI dispersion maps and from 3T MRI modalities at baseline at stroke onset.

Time frame
Baseline at stroke onset
2

Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients

Comparison of infarct core volumes on 30-day 3T FLAIR and baseline/30-day FCI T1 dispersion maps in ischaemic stroke patients.

Time frame
30 days after stroke onset
3

Agreement between T1 dispersion curve measurements obtained from in vivo clot in large intracerebral vessels and clot formed in vitro.

Extent of agreement between quantified T1 dispersion curve measurements obtained from in vivo imaging and benchtop Fast Field Cycling Nuclear Magnetic Resonance (FFC-NMR). Extent of correlation between thrombo-elastography measurements against in vivo measurements of T1 dispersion.

Time frame
At baseline and 30 days after stroke onset

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

NHS Grampian

Collaborator

Source ClinicalTrials.gov
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