Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327334
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-18
Brief Title:
Brain Heart InterActioNs in Cardiac Arrest Ancillary Study of the HEAVENwARd Trial
Sponsor:
CMC Ambroise Paré
Organization:
CMC Ambroise Paré
Study Overview
Official Title:
Brain Heart InterActioNs in Cardiac Arrest Ancillary Study of the HEAVENwARd Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BHIANCA
Brief Summary:
Despite advances in post-resuscitation care of patients with cardiac arrest CA the majority of survivors who are treated after restoration of spontaneous circulation ROSC will have sequelae of hypoxic-ischemic brain injury ranging from mild cognitive impairment to a vegetative state Current recommendations suggest using a multimodal approach to predict poor prognosis meaning combining markers together Yet a substantial proportion of patients do not have a clear prognostic evaluation even when applying the latest ESICM recommendations algorithm published in 2021 It is therefore important to identify new prognostic markers to predict both unfavorable and favorable outcomes Data regarding the pathophysiological mechanisms of post-anoxic encephalopathy suggest a diffuse anoxo-ischemic injury However post-mortem neuropathology data suggest that these lesions do not uniformly affect neuroanatomical structures with some regions especially hippocampal and insular appearing more sensitive to anoxia Conversely the brainstem appears less affected by anoxic lesions Under physiological conditions there are interactions between the heart and the brain and between the brain and the heart mainly related to the autonomic nervous system through interactions between central cortical control structures especially insular and brainstem structures at the level of the bulb and peripheral structures of the heart Exploring the pathophysiological mechanisms of heart-brain interactions post-CA could thus help better understand the pathophysiology of anoxo-ischemic encephalopathy before considering potential therapeutic targets Furthermore this heart-brain dysfunction could have prognostic value Indeed recent studies in healthy subjects and patients with consciousness disorders suggest that autonomic nervous system activity measured by brain-heart interactions could be a reliable marker of consciousness and cognitive processing These coupled heart-brain interactions can be evaluated through synchronous electroencephalogram EEG and electrocardiogram ECG recordings as there are coupled interactions between the signals of these two organs The existence of abnormal brain-heart coupling could be associated on the one hand with the severity of post-anoxic encephalopathy and on the other hand with neurological prognosis in patients with persistent coma post-CA
This ancillary study of a multicentre prospective cohort HEAVENwARd study NCT06044922 will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA
This ancillary study of a multicentre prospective cohort HEAVENwARd study NCT06044922 will assess the prevalence and prognostic value of bilateral brain-heart interactions in comatose patients after CA
Detailed Description:
The study BHIANCA will be an ancillary study of the HEAVENwARd study HEart rAte Variability in Early prediction of a Noxic brain injury after cardiac ARrest NCT06044922
All patients included in the HEAVENwARd study who have an EEG with ECG lead recorded for a neuroprognostication are eligible
All patients included in the HEAVENwARd study who have an EEG with ECG lead recorded for a neuroprognostication are eligible
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None