[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563531":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":51,"sex":57,"minAge":58,"maxAge":19,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"anoxo-ischemic coma patients","EXPERIMENTAL","Standard multimodal prognostication procedure will be followed, including the collection of standard predictors:\n\ni) clinical examination and behavioral data (Day 1, 3 and 7 after inclusion): Glasgow Coma Scale - GCS, Full Outline of UnResponsiveness - FOUR,Coma Recovery Scale Revised - CRS-R; and standardized brainstem reflex testing (FOUR, Glasgow-Liège score); ii) severity stratification scoring (Day 1 after inclusion): Cardiac Arrest Hospital Prognosis - CAHP, Out-of-Hospital Cardiac Arrest - OHCA, iii) laboratory findings (Day 1) : NSE blood level iv) electrophysiological assessments (once between Day 1 and Day 15 after inclusion): standard EEG following current guidelines and using ACNS classification; v) standard neuroimaging (once between Day 1 and Day 15 after inclusion): standard brain CT or MRI data (T1, T2\\*, SWI, DWI, FLAIR).\n\nAn advanced wholebrain sMRI\u002FfMRI\u002Fcontrast-enhanced MRI scan will be acquired (between Day 1 and Day 7 after inclusion).",[13],"Other: advanced whole-brain sMRI\u002FfMRI\u002Fcontrast-enhanced MRI scan",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"advanced whole-brain sMRI\u002FfMRI\u002Fcontrast-enhanced MRI scan","advanced whole-brain sMRI\u002FfMRI\u002Fcontrast-enhanced MRI scan (estimated total scanning time = 45 min for all centers except for Toulouse = 60min) will be acquired at least after 72h from complete withdrawal of sedation in normothermia condition (between Day 1 and Day 7 after inclusion).",[9],null,[21],{"name":22,"affiliation":23,"role":24},"Stein SILVA, MD PhD","University Hospital of Toulouse","PRINCIPAL_INVESTIGATOR",[26],{"name":22,"role":27,"phone":28,"phoneExt":29,"email":30},"CONTACT","0561772288","+33","silva.s@chu-toulouse.fr",[32],{"facility":33,"status":34,"city":35,"state":19,"zip":19,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"UHToulouse","RECRUITING","Toulouse","France","FR",{"type":39,"coordinates":40},"Point",[41,42],1.44367,43.60426,{"lat":42,"lon":41},[45],{"name":46,"role":27,"phone":19,"phoneExt":19,"email":19},"Stein SILVA, PU-PH",{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100563531","combined-whole-brain-structural-and-functional-mri-for-the-prediction-of-neurological-recovery-after-cardiac-arrest-100563531",false,"NCT06617377","Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest","Use of Brain Structural and Functional Connectomes for the Prediction of Neurological Recovery in Coma Patients After Cardiac Arrest","ARISE","Inclusion Criteria:\n\n* Adult patients (male or female ≥ 18 years).\n* Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset.\n* Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions.\n* Written informed consent from patient's legal representative.\n* Affiliation or beneficiary to the French social security system.\n\nExclusion Criteria:\n\n* Brain death.\n* Coma explained by other cause than CA.\n* Likely poor neurological outcome based on early predictors, following ERC-ESCIM 2021 recommendations. In a comatose patient with GCS motor score ≤ 3 at ≥ 72 h from ROSC, in the absence of confounders, the identification of at least two of the following: bilaterally absent pupillary light and corneal reflexes at ≥ 72h, bilaterally absent N20 SSEP ≥ 24h; neuron-specific enolase (NSE) \\> 60 μg\u002Fl at 48h and\u002For 72h, status myoclonus ≤72h.\n* Decision of WLST previous to patient recruitment, based on early predictors of poor neurological outcome, age, co-morbidity, general organ function and patient's preferences.\n* Life expectancy shorter than 6 months based on pre-morbid conditions.\n* Former neurological functional disability (mRS \\> 2 before CA).\n* MRI contraindication: medical material not MRI compatible, claustrophobia\n* Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium\n* Severe kidney failure defined as a KDIGO score \\> 3 (glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73 m2 or renal replacement therapy).\n* Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning.\n* Pregnancy or nursing woman.\n* Patient under juridical protection.","ALL","18 Years",{"count":60,"type":61},263,"ESTIMATED","INTERVENTIONAL",[64],"NA","To assess the performance of a predictive model resulting from the analysis of sMRI\u002FfMRI\u002Fcontrast-enhanced MRI-derived personalized connectomic data, as compared with standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict anoxoischemic coma neurological outcome at 6 months.",[67,68,69,70],"Coma","Cardiac Arrest","Disorder of Consciousness","Neurologic Disorder",[72,73,74,75,76,77],"prognosis","coma","cardiac arrest","Structural MRI","resting-state","cognitive motor dissociation","2026-06-24",{"date":80,"type":81},"2026-06-29","ACTUAL",{"date":83,"type":81},"2026-03-16",{"date":85,"type":61},"2029-09",{"name":5,"class":6},1]