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Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
RECRUITINGN/ASponsored by University Hospital, Toulouse
Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Toulouse
Started2026-03-16
Est. completion2029-09
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06617377
Summary
To assess the performance of a predictive model resulting from the analysis of sMRI/fMRI/contrast-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.
Eligibility
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: * Adult patients (male or female ≥ 18 years). * Coma, as indicated by a Glasgow Coma Scale (GCS) ≤ 8 (motor score ≤ 2) immediately after CA resuscitation and before sedation onset. * Persisting unconsciousness, defined as the inability to obey verbal commands, after at least 72 hours from complete withdrawal of sedation in normothermia conditions. * Written informed consent from patient's legal representative. * Affiliation or beneficiary to the French social security system. Exclusion Criteria: * Brain death. * Coma explained by other cause than CA. * 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/l at 48h and/or 72h, status myoclonus ≤72h. * 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. * Life expectancy shorter than 6 months based on pre-morbid conditions. * Former neurological functional disability (mRS \> 2 before CA). * MRI contraindication: medical material not MRI compatible, claustrophobia * Known hypersensitivity to gadoteric acid, meglumin or any drug containing gadolinium * Severe kidney failure defined as a KDIGO score \> 3 (glomerular filtration rate \< 30 ml/min/1.73 m2 or renal replacement therapy). * Hemodynamic shock or severe respiratory failure precluding patient's transport and MRI scanning. * Pregnancy or nursing woman. * Patient under juridical protection.
Conditions5
Cardiac ArrestComaDisorder of ConsciousnessHeart DiseaseNeurologic Disorder
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Actively Recruiting
PhaseN/A
SponsorUniversity Hospital, Toulouse
Started2026-03-16
Est. completion2029-09
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06617377