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临床试验/NCT07789990
NCT07789990尚未招募不适用

Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI

University Hospital, Lille0 个研究点目标入组 48 人开始时间: 2026年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
48
主要终点
Intraclass coefficient correlation (ICC)

研究概览

简要总结

Intracerebral haemorrhage is the type of stroke with the highest mortality rate, estimated at 40% in the acute phase. Among survivors, half will experience functional disability. Currently, there is no validated effective treatment. Reduction of perihematomal oedema is a potential therapeutic target. The development of oedema in the days following the haemorrhage worsens functional prognosis, notably through a harmful inflammatory process. In the early phase, neuronal excitotoxicity induced by the hematoma plays a major role in triggering the inflammatory cascade. This phenomenon is associated with dysfunction of neuronal Na⁺/K⁺ ATPase pumps and a disturbance of cerebral sodium homeostasis. Ultra-high field 7T MRI enables in vivo quantification of brain sodium concentrations. The investigators hypothesize that a drop-in sodium concentration within the perihematomal oedema is associated with greater oedema expansion and poorer functional outcome. To make this biomarker accessible to centers without 7 Tesla MRI, the investigators will use an artificial intelligence algorithm to generate synthetic sodium concentration maps derived from data acquired on conventional 3 Tesla MRI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 80 years old;
  • presenting for a first-ever or recurrent symptomatic supratentorial spontaneous ICH within 8 (±2) days after symptoms onset (or last seen well) and confirmed by brain imaging; presumed to be related to small vessel disease.
  • Patient/legal representative/trusted person who has given written consent to participate in the trial;
  • Patient covered by social security in France
  • Patient willing to comply with all study procedures and its duration

排除标准

  • Contra-indication for MRI;
  • pre-admission disabilities (mRs > 4);
  • large ICH of 60 ml or more;
  • NIH Stroke Scale score > 20;
  • item 1a of NIH Stroke Scale (level consciousness) > 0;
  • surgical evacuation of ICH, associated intraventricular haemorrhage; ICH due to preceding trauma; ICH suspected to result from an identified intracranial vascular malformation, intracranial venous thrombosis, tumor or haemorrhagic transformation within an infarct.
  • Epileptic seizure within 48 hours prior to inclusion or anti-epileptic treatment
  • Patient in the intensive care unit who is intubated and on a ventilator
  • Pregnancy

研究组 & 干预措施

7Tesla Sodium MRI

Experimental

干预措施: Sodium tissue concentration will be measured in perihematomal oedema (Device)

结局指标

主要结局

Intraclass coefficient correlation (ICC)

时间窗: Baseline visit

Intraclass coefficient correlation (ICC) between sodium concentration measured at 7T and synthetic sodium concentration calculated from 3T images assessed at day-8 after ICH onset.

次要结局

  • Correlation coefficients of 6-month disability degree and sodium concentration.(Baseline and 6-month visit)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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