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Recruiting NCT07004140

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

— Observational Stroke Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3T MRI research scan, Field-Cycling Imaging research scan, Follow up 3T MRI research scan, Follow up Field-Cycling Imaging research scan.
Who it may be relevant to
Registry conditions: Stroke Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other 3T MRI research scan
    Baseline MRI scan
  • Other Field-Cycling Imaging research scan
    Baseline FCI scan
  • Other Follow up 3T MRI research scan
    Day 30 3T MRI scan
  • Other Follow up Field-Cycling Imaging research scan
    Day 30 FCI scan
  • Other Blood samples for clotting experiments in vitro
    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.

Primary outcome measures

  • Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline [Time frame: Baseline at stroke onset]
Secondary outcome measures (3)
  • Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline [Time frame: Baseline at stroke onset]
  • Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients [Time frame: 30 days after stroke onset]
  • Agreement between T1 dispersion curve measurements obtained from in vivo clot in large intracerebral vessels and clot formed in vitro. [Time frame: At baseline and 30 days after stroke onset]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Contraindications to MRI.
  • Medically unstable.
  • Unable to comprehend or comply with instructions regarding scanning
  • Prior mRS of >3.
  • Identified for thrombectomy.
  • Non-stroke pathology or previous cortical infarct on CT scan > 1/3 of middle cerebral artery territory.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • University of Aberdeen — Aberdeen

Publications

  • Mallikourti V, Ross PJ, Maier O, Guzman-Gutierrez G, Franko E, Lurie DJ, Broche LM, Macleod MJ. Field-Cycling MRI for Identifying Minor Ischemic Stroke Below 0.2 T. Radiology. 2024 Aug;312(2):e232972. doi: 10.1148/radiol.232972. PMID 39189899
  • Senn N, Ross PJ, Ayde R, Mallikourti V, Krishna A, James C, de Vries CF, Broche LM, Waiter GD, MacLeod MJ. Field-cycling imaging yields repeatable brain R1 dispersion measurement at fields strengths below 0.2 Tesla with optimal fitting routine. MAGMA. 2025 Jul;38(3):465-474. doi: 10.1007/s10334-025-01230-w. Epub 2025 Feb 15. PMID 39955477

Identifiers

NCT: NCT07004140 · 2-001-25 · 25/SS/0021

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗