Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest

NCT06617377 | Not Yet Recruiting

• 2 other identifiers: RC31/22/0259N° ID-RCB
• Study Type: interventional
• Target: 263
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coma; Cardiac Arrest; Disorder of Consciousness; Neurologic Disorder

Keywords

prognosis; coma; cardiac arrest; Structural MRI; resting-state; cognitive motor dissociation

Outcome Measures

Primary Outcomes (1)

• 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).

  month 6

Secondary Outcomes (2)

• Performance of a predictive model to predict neurological outcome at hospital discharge

  Hospital discharge

• Performance of a predictive model to predict neurological outcome at 3 months after CA

  month 3

Study Arms (1)

anoxo-ischemic coma patients

EXPERIMENTAL

Standard multimodal prognostication procedure will be followed, including the collection of standard predictors: i) clinical examination and behavioral data (Day 1, 3 and 7 after inclusion): Glasgow Coma Scale - GCS, Full Outline of UnResponsiveness - FOUR,Coma Recovery Scale Revised - CRS-R; and standardized brainstem reflex testing (FOUR, Glasgow-Liège score); ii) severity stratification scoring (Day 1 after inclusion): Cardiac Arrest Hospital Prognosis - CAHP, Out-of-Hospital Cardiac Arrest - OHCA, iii) laboratory findings (Day 1) : NSE blood level iv) electrophysiological assessments (once between Day 1 and Day 15 after inclusion): standard EEG following current guidelines and using ACNS classification; v) standard neuroimaging (once between Day 1 and Day 15 after inclusion): standard brain CT or MRI data (T1, T2\*, SWI, DWI, FLAIR). An advanced wholebrain sMRI/fMRI/contrast-enhanced MRI scan will be acquired (between Day 1 and Day 7 after inclusion).

Other: advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan

Interventions

advanced whole-brain sMRI/fMRI/contrast-enhanced MRI scan OTHER

advanced 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).

anoxo-ischemic coma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

MeSH Terms

Conditions

Coma; Heart Arrest; Consciousness Disorders; Nervous System Diseases

Condition Hierarchy (Ancestors)

Unconsciousness; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Stein SILVA, MD PhD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stein SILVA, MD PhD

CONTACT

0561772288; silva.s@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: anoxo-ischemic coma patients

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 27, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share