An observational study in Cardiac Arrest, sponsored by CMC Ambroise Paré. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-27.
Sponsored by CMC Ambroise Paré · Observational
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.
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.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 376 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Comatose patients admitted in ICU after resuscitation from cardiac arrest
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilateral brain-heart interactions
Coupling coefficient between the time-varying power of EEG in different frequency bands and heart rate variability metrics reflecting sympathetic and parasympathetic tone will be compared between post-cardiac arrest patients and normal values in healthy subjects (already acquired database coming from Monin et al. Neurophysiologie Clinique 2018).
Time frame: At day-28
Poor neurological outcome evaluated using the CPC score
The CPC (Cerebral Performance Category) score assesses neurological status after cardiac arrest on a scale of 1 to 5 (1 = conscious and normal; 2 = conscious with moderate disability; 3 = conscious with severe disability; 4 = coma or vegetative state; 5 = death). The CPC score will be dichotomized as follow: good neurological outcome for categories 1 and 2 and poor neurological outcome or death for categories 3, 4 and 5. The CPC score will be obtained at day-28 from an in-hospital visit if the patient is still hospitalized or by phone call if patient returned home.
Time frame: At day-28
Mortality
Time frame: At day-28
Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE).
Time frame: At day-28
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2027, 36 months after the start.
Of 169 non-industry observational studies under Heart Arrest, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 90. This study's planned 36 months is close to that.
Counting every sponsor, half of 176 studies reached it within 41 months; a quarter within 18 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CMC Ambroise Paré