[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653659":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":25,"interventions":31,"overallOfficials":18,"centralContacts":36,"locations":18,"responsibleParty":43,"collaborators":45,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":18,"studyType":64,"phases":65,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":76,"whyStopped":18,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":18},{"fullName":5,"class":6},"University Hospital, Lille","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Intraclass coefficient correlation (ICC)","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.","Baseline visit",[14],{"measure":15,"description":16,"timeFrame":17},"Correlation coefficients of 6-month disability degree and sodium concentration.","Correlation coefficients of 6-month disability degree assessed by modified Rankin scale (mRS) with 7T and 3T synthetic sodium concentration at day-8 after ICH onset.","Baseline and 6-month visit",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":18,"primaryPurpose":22,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":24,"maskingDescription":18,"whoMasked":18},"NONE",[26],{"label":27,"type":28,"description":18,"interventionNames":29},"7Tesla Sodium MRI","EXPERIMENTAL",[30],"Device: Sodium tissue concentration will be measured in perihematomal oedema",[32],{"type":33,"name":34,"description":34,"armGroupLabels":35,"otherNames":18},"DEVICE","Sodium tissue concentration will be measured in perihematomal oedema",[27],[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Grégory KUCHCINSKI Hospital Practitioner, MD,PhD","CONTACT","0320446468","+33","gregory.kuchcinski@chu-lille.fr",{"type":44,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[46,48],{"name":47,"class":6},"Lille University",{"name":49,"class":50},"Lille In vivo Imaging and Functional Exploration","UNKNOWN","100653659","characterization-of-peri-hemorrhagic-cerebral-edema-using-synthetic-sodium-imaging-with-7-tesla-and-3-tesla-mri-100653659",false,"NCT07789990","Characterization of Peri-Hemorrhagic Cerebral Edema Using Synthetic Sodium Imaging With 7-Tesla and 3-Tesla MRI","TIPITCH-7T","Inclusion Criteria:\n\n* Patients aged between 18 and 80 years old;\n* 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.\n* Patient\u002Flegal representative\u002Ftrusted person who has given written consent to participate in the trial;\n* Patient covered by social security in France\n* Patient willing to comply with all study procedures and its duration\n\nExclusion Criteria:\n\n* Contra-indication for MRI;\n* pre-admission disabilities (mRs \\> 4);\n* large ICH of 60 ml or more;\n* NIH Stroke Scale score \\> 20;\n* item 1a of NIH Stroke Scale (level consciousness) \\> 0;\n* 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.\n* Epileptic seizure within 48 hours prior to inclusion or anti-epileptic treatment\n* Patient in the intensive care unit who is intubated and on a ventilator\n* Pregnancy","ALL","18 Years","80 Years",{"count":62,"type":63},48,"ESTIMATED","INTERVENTIONAL",[20],"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⁺\u002FK⁺ 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.",[68],"Intracerebral Haemorrhage, ICH",[70,71,72,73,74,75],"Magnetic Resonance Imaging","Sodium","Artificial Intelligence","Stroke","Intracerebral hemorrhage","Oedema","NOT_YET_RECRUITING","2026-08-27",{"date":79,"type":80},"2026-09-01","ACTUAL",{"date":79,"type":63},{"date":83,"type":63},"2029-03-01",{"name":5,"class":6}]