Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery Af… (NCT06617377) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
263 participantsStarted 2025-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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
* …
What they're measuring
1
performance of a predictive model to predict 6 months neurological outcome