Clinical trial NCT06327334: Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial
Official title: Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Arrest
Keywords: Brain-heart interactions
Resuscitated cardiac arrest
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Comatose patients admitted in ICU after resuscitation from cardiac arrest

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.

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.

Eligibility criteria: Inclusion Criteria:

* Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
* Coma (Glasgow score \< 8) after ROSC, requiring sedation and targeted temperature management for at least 24h
* EEG with ECG lead performed in routine care

Exclusion Criteria:

* Dying patient (Limitation of life support techniques at admission to the ICU)
* Limitation of life sustaining treatment before EEG
* Non-Sinus Rhythm
* Pregnant or breastfeeding women
* Patient under protection of the adults (guardianship, curators or safeguard of justice)
* Opposition by the trusted person or by the patient

Primary outcomes:
measure: Bilateral brain-heart interactions
timeFrame: At day-28
Secondary outcomes:
measure: Poor neurological outcome evaluated using the CPC score
timeFrame: At day-28
measure: Mortality
timeFrame: At day-28
measure: Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE).
timeFrame: At day-28
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
state: Bretagne
city: Neuilly-sur-Seine
country: France
facility: Ambroise Paré - Hartmann Private Hospital Group
state: Ile-de-France
city: Paris
country: France
facility: Cochin Hospital
state: Ile-de-France
city: Nantes
country: France
facility: Nantes University Hospital
state: Pays de la Loire
city: Marseille
country: France
facility: Marseille University Hospital
state: Provence Alpes Cote d Azur
Study officials:
References: