About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan
Other interventionadvanced whole-brain sMRI/fMRI/contrast-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).
Treatment groups
Trial outcomes
Primary outcomes
performance of a predictive model to predict 6 months neurological outcome
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI), or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict 6 months neurological outcome as measured by the dichotomized Rankin Scale (mRS).
Secondary outcomes
Performance of a predictive model to predict neurological outcome at hospital discharge
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI) or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict neurological outcome at hospital discharge after CA by the dichotomized Rankin Scale (mRS).
Performance of a predictive model to predict neurological outcome at 3 months after CA
Comparison between the area under the Receiver Operating Characteristic (ROC) curves of outcomes prediction models, based on either MRI-derived indicators (structural, functional and contrast-enhanced MRI) or built upon standard predictors (clinical examination, electrophysiology, serum biomarker, standard neuroimaging) both collected ≥ 72h from sedation withdrawal and in normothermia condition, to predict neurological outcome at 3 months after CA by the dichotomized Rankin Scale (mRS).
Sponsors and contacts
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