Proving Utility of a New Field-cycling MRI Prototype in Acute Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Contraindications to MRI.
- •Medically unstable.
- •Unable to comprehend or comply with instructions regarding scanning
- •Prior mRS of >
- •Identified for thrombectomy.
- •Non-stroke pathology or previous cortical infarct on CT scan > 1/3 of middle cerebral artery territory.
研究组 & 干预措施
Ischaemic stroke
Ischaemic stroke patients within 24 hours from symptom onset
干预措施: 3T MRI research scan (Other)
Ischaemic stroke
Ischaemic stroke patients within 24 hours from symptom onset
干预措施: Field-Cycling Imaging research scan (Other)
Ischaemic stroke
Ischaemic stroke patients within 24 hours from symptom onset
干预措施: Follow up 3T MRI research scan (Other)
Ischaemic stroke
Ischaemic stroke patients within 24 hours from symptom onset
干预措施: Follow up Field-Cycling Imaging research scan (Other)
Ischaemic stroke
Ischaemic stroke patients within 24 hours from symptom onset
干预措施: Blood samples for clotting experiments in vitro (Other)
Haemorrhagic stroke
Patients with primary intracerebral haemorrhage within 24 hours from symptom onset
干预措施: 3T MRI research scan (Other)
Haemorrhagic stroke
Patients with primary intracerebral haemorrhage within 24 hours from symptom onset
干预措施: Field-Cycling Imaging research scan (Other)
结局指标
主要结局
Agreement between extent of ischaemic stroke at-risk tissue/infarct core obtained from FCI dispersion maps and 3T MRI modalities at baseline
时间窗: Baseline at stroke onset
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.
次要结局
- Agreement between extent of haemorrhagic volume obtained from FCI dispersion maps and 3T MRI modalities at baseline(Baseline at stroke onset)
- Agreement of infarct core volume measurements obtained from FCI and 3T MRI at day 30 in ischaemic stroke patients(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.(At baseline and 30 days after stroke onset)