NCT06617377 Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
| NCT ID | NCT06617377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Coma |
| Study Type | INTERVENTIONAL |
| Enrollment | 263 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2029-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 263 participants in total. It began in 2026-03-16 with a primary completion date of 2029-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Stein SILVA, MD PhD
PRINCIPAL INVESTIGATOR
University Hospital of Toulouse
Frequently Asked Questions
Who can join the NCT06617377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06617377 currently recruiting?
Yes, NCT06617377 is actively recruiting participants. Contact the research team at silva.s@chu-toulouse.fr for enrollment information.
Where is the NCT06617377 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06617377 clinical trial?
NCT06617377 is sponsored by University Hospital, Toulouse. The principal investigator is Stein SILVA, MD PhD at University Hospital of Toulouse. The trial plans to enroll 263 participants.