Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617377
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-24
Brief Title:
Combined Whole-brain Structural and Functional MRI for the Prediction of Neurological Recovery After Cardiac Arrest
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of Brain Structural and Functional Connectomes for the Prediction of Neurological Recovery in Coma Patients After Cardiac Arrest
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARISE
Brief Summary:
To assess the performance of a predictive model resulting from the analysis of sMRIfMRIcontrast-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
Detailed Description:
There is a major need for timely reliable and generalizable methods to predict outcomes in anoxo-ischemic coma patients Standard predictors of poor outcome after cardiac arrest CA include clinical electrophysiological and serum biomarkers data All have substantial limitations in terms of reliability and generalizability By providing whole-brain structural and functional connectivity maps or connectomes advanced MRI techniques have precisely revealed the brain network damages induced by CA Because these individualized connectomic profiles contains critical information about consciousness recovery potential after CA it can be hypothesized that these whole-brain quantitative data can be used to elaborate highly performant predictive algorithms for anoxo-ischemic coma patients
Regarding advanced structural MRI sMRI two recent studies including one from the investigators group have shown a high sensitivity and specificity of these advanced techniques diffusion tensor imaging -DTI voxel-based morphometry -VBM for predicting poor neurological recovery in anoxo-ischemic patients However these two studies collected data using poorly defined time window for MRI across lengthy data collection periods 8 years and did not apply a strict protocol of withdrawal or limitation-of-care decision to control from misclassification of outcome due to so-called selffulfilling prophecies Concerning functional MRI fMRI a recent study from the investigators group reports that the strength of frontoparietal functional connectivity differs between anoxo-ischemic coma patients who recover and those who eventually score an unfavorable outcome at 3 months
Furthermore converging evidence suggest that task-based fMRI can be used to detect active command-following modulation of cortical activity and hence consciousness in behaviorally unresponsive patients This task-based fMRI pattern named Cognitive Motor Dissociation CMD show promise of radically improving good outcome neuroprognostication after CA Finally aiming to maximize the performance of MRI-derived predictive models the investigators group have recently reported in a proof-of-concept study that a combined sMRIfMRI connectomes and contrast-enhanced MRI data analysis synergistically outperform alternative predictive models based on sMRI or fMRI data in isolation
As recommended in recent guidelines for the management of anoxo-ischemic coma patients7-9 a standard multimodal prognostication procedure will be followed including the collection of standard predictors after at least 72h from complete withdrawal of sedation in normothermia condition 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 - CRSR 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 3 and 7 after inclusion NSE blood level Day 1 iv electrophysiological assessments standard EEG using ACNS classification once between Day 1 and Day 15 after inclusion v standard neuroimaging once between Day 1 and Day 15 after inclusion standard brain CT or MRI data T1 T2 SWI DWI FLAIR
In addition to standard clinical neuroprognostication procedure an advanced whole-brain sMRIfMRIcontrast-enhanced MRI scan will be acquired at least after 72h from complete withdrawal of sedation in normothermia condition between Day 1 and Day 7 after inclusion
sMRIfMRI contrast-enhanced MRI data will be collected during the same scanning plot that will be used for standard MRI T1 T2 SWI DWI FLAIR will encompass total acquisition time 45 min for all centers except for Toulouse center 60 min
Structural MRI total acquisition time 30 min i gray matter 3D T1-weithed data will be computed to assess whole brain cortical thickness and deep gray matter quantitative volumetry ii white matter whole-brain DTI will be acquired to measure whole brain with matter fractional anisotropy WWM-FA and mean average diffusion coefficient WB-aDC A normalization procedure will be applied healthy controls data from each neuroimaging facility
Functional MRI total acquisition time 10 min for all centers except for Toulouse center 25 min i passive-task multislice T2-weighted for resting-state fMRI analysis images acquisition time 10 min ii active tasks fMRI will be used to probe for volitional thought without selfexpression output motor imagery and motor action acquisition time 15 min only for Toulouse center
Contrast-enhanced MRI acquisition time 5 min for blood-brain barrier permeability assessment As exploratory goals and seeking to i study the potential changes over time of advanced brain sMRIfMRIcontrast-enhanced MRI data a second identical advanced sMRIfMRIcontrastenhanced MRI will be performed minimum 7 days with an allowance of 3 days after the first MRI assessment in patients enrolled in Toulouse center N 30 ii To investigate the usefulness for patients neuroprognostication of novel brain injury fluid-derived biomarkers ref three peripheral blood samples will be collected two times each sample blood volume 5 ml a first one immediately at patients inclusion and second one 7 days later N 30 only for Toulouse center
To gauge the clinical significance of this findings the investigators plan to use largely validated neurological functional score mRS CPCs Additionally the investigator plan to explore as secondary evaluation criteria patients level of consciousness CRS-R and the restauration of the pre-arrest health-related quality of life HRQOL These assessments will be performed at hospital discharge mRS CPC and at 3 mRS CPC and 6 months mRS CPC CRS-R HRQOL after CA by specifically trained investigators during the planned follow-up visit Patients medical care will be not be influenced by patients study participation because the treating teams will be fully blinded to advanced sMRIfMRIcontrast-enhanced MRI data Figure 3 Patients management will be performed in agreement with international guidelines A strict and homogenous WLST protocol will be used in all the recruiting centers
Regarding advanced structural MRI sMRI two recent studies including one from the investigators group have shown a high sensitivity and specificity of these advanced techniques diffusion tensor imaging -DTI voxel-based morphometry -VBM for predicting poor neurological recovery in anoxo-ischemic patients However these two studies collected data using poorly defined time window for MRI across lengthy data collection periods 8 years and did not apply a strict protocol of withdrawal or limitation-of-care decision to control from misclassification of outcome due to so-called selffulfilling prophecies Concerning functional MRI fMRI a recent study from the investigators group reports that the strength of frontoparietal functional connectivity differs between anoxo-ischemic coma patients who recover and those who eventually score an unfavorable outcome at 3 months
Furthermore converging evidence suggest that task-based fMRI can be used to detect active command-following modulation of cortical activity and hence consciousness in behaviorally unresponsive patients This task-based fMRI pattern named Cognitive Motor Dissociation CMD show promise of radically improving good outcome neuroprognostication after CA Finally aiming to maximize the performance of MRI-derived predictive models the investigators group have recently reported in a proof-of-concept study that a combined sMRIfMRI connectomes and contrast-enhanced MRI data analysis synergistically outperform alternative predictive models based on sMRI or fMRI data in isolation
As recommended in recent guidelines for the management of anoxo-ischemic coma patients7-9 a standard multimodal prognostication procedure will be followed including the collection of standard predictors after at least 72h from complete withdrawal of sedation in normothermia condition 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 - CRSR 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 3 and 7 after inclusion NSE blood level Day 1 iv electrophysiological assessments standard EEG using ACNS classification once between Day 1 and Day 15 after inclusion v standard neuroimaging once between Day 1 and Day 15 after inclusion standard brain CT or MRI data T1 T2 SWI DWI FLAIR
In addition to standard clinical neuroprognostication procedure an advanced whole-brain sMRIfMRIcontrast-enhanced MRI scan will be acquired at least after 72h from complete withdrawal of sedation in normothermia condition between Day 1 and Day 7 after inclusion
sMRIfMRI contrast-enhanced MRI data will be collected during the same scanning plot that will be used for standard MRI T1 T2 SWI DWI FLAIR will encompass total acquisition time 45 min for all centers except for Toulouse center 60 min
Structural MRI total acquisition time 30 min i gray matter 3D T1-weithed data will be computed to assess whole brain cortical thickness and deep gray matter quantitative volumetry ii white matter whole-brain DTI will be acquired to measure whole brain with matter fractional anisotropy WWM-FA and mean average diffusion coefficient WB-aDC A normalization procedure will be applied healthy controls data from each neuroimaging facility
Functional MRI total acquisition time 10 min for all centers except for Toulouse center 25 min i passive-task multislice T2-weighted for resting-state fMRI analysis images acquisition time 10 min ii active tasks fMRI will be used to probe for volitional thought without selfexpression output motor imagery and motor action acquisition time 15 min only for Toulouse center
Contrast-enhanced MRI acquisition time 5 min for blood-brain barrier permeability assessment As exploratory goals and seeking to i study the potential changes over time of advanced brain sMRIfMRIcontrast-enhanced MRI data a second identical advanced sMRIfMRIcontrastenhanced MRI will be performed minimum 7 days with an allowance of 3 days after the first MRI assessment in patients enrolled in Toulouse center N 30 ii To investigate the usefulness for patients neuroprognostication of novel brain injury fluid-derived biomarkers ref three peripheral blood samples will be collected two times each sample blood volume 5 ml a first one immediately at patients inclusion and second one 7 days later N 30 only for Toulouse center
To gauge the clinical significance of this findings the investigators plan to use largely validated neurological functional score mRS CPCs Additionally the investigator plan to explore as secondary evaluation criteria patients level of consciousness CRS-R and the restauration of the pre-arrest health-related quality of life HRQOL These assessments will be performed at hospital discharge mRS CPC and at 3 mRS CPC and 6 months mRS CPC CRS-R HRQOL after CA by specifically trained investigators during the planned follow-up visit Patients medical care will be not be influenced by patients study participation because the treating teams will be fully blinded to advanced sMRIfMRIcontrast-enhanced MRI data Figure 3 Patients management will be performed in agreement with international guidelines A strict and homogenous WLST protocol will be used in all the recruiting centers
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None