Combined whole-brain MRI to predict recovery after cardiac arrest

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect advanced structural and functional MRI data (including contrast-enhanced scans) from adults who remain unconscious 72 hours after cardiac arrest, and compare a connectome-based predictive model with traditional predictors such as clinical exams, electrophysiology, serum biomarkers, and standard imaging. The goal is to see if the MRI-derived brain network information can improve accuracy in predicting poor or favorable outcomes at 6 months. The study uses a standardized imaging protocol during normothermia and after sedation withdrawal, alongside established predictors. It is led by University Hospital, Toulouse, and aims to reduce misclassification related to self-fulfilling prophecies through strict timing and criteria. The approach builds on prior work suggesting that individualized brain connectivity reflects consciousness recovery potential.

Why it matters

Who can join: the full rules

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.

Where it's running

• UHToulouse
  Toulouse, France Recruiting

Study contacts

• Principal investigator: Stein SILVA, MD PhD — University Hospital of Toulouse
• Study coordinator: Stein SILVA, MD PhD
• Email: silva.s@chu-toulouse.fr
• Phone: 0561772288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.