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

Обзор

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.

Вмешательства

• Другое 3T MRI research scan
  Baseline MRI scan
• Другое Field-Cycling Imaging research scan
  Baseline FCI scan
• Другое Follow up 3T MRI research scan
  Day 30 3T MRI scan
• Другое Follow up Field-Cycling Imaging research scan
  Day 30 FCI scan
• Другое 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.

Первичные конечные точки

• Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline [Срок оценки: Baseline at stroke onset]

Вторичные конечные точки (3)

• Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline [Срок оценки: Baseline at stroke onset]
• Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients [Срок оценки: 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. [Срок оценки: At baseline and 30 days after stroke onset]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• University of Aberdeen — Aberdeen

Публикации

• 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

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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