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NCT07789990
Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI
Conditions: Intracerebral Haemorrhage, ICH
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: University Hospital, Lille
Summary
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. We 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, we will use an artificial intelligence algorithm to generate synthetic sodium concentration maps derived from data acquired on conventional 3 Tesla MRI.
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07789990). StuddyBuddy aggregates publicly available trial information.