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