| Registry | NCT07789990, acronym TIPITCH-7T |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 48 (Estimated) |
| Sponsor | University Hospital, Lille (Other); collaborators: Lille University, Lille In vivo Imaging and Functional Exploration |
| Conditions | Intracerebral Haemorrhage, ICH |
| Interventions | Sodium tissue concentration will be measured in perihematomal oedema (Device) |
| Dates | start 2026-09-01 (estimated), primary completion 2028-09-15 (estimated), completion 2029-03-01 (estimated), first posted 2026-08-27, last updated 2026-09-01 |
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All trials for Intracerebral Haemorrhage, ICH All trials of Sodium tissue concentration will be measured in perihematomal oedema
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 7Tesla Sodium MRI | Experimental | Device: Sodium tissue concentration will be measured in perihematomal oedema |
Sex: All, ages: 18 Years to 80 Years
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