Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial

NCT06327334 | Recruiting

• 1 other identifier: 2023/03
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiac Arrest

Keywords

Brain-heart interactions; Resuscitated cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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).

  At day-28

Secondary Outcomes (3)

• Poor neurological outcome evaluated using the CPC score

  At day-28

• Mortality

  At day-28

• Post-anoxic encephalopathy severity evaluated by composite prognostic markers combining EEG patterns, somatosensory evoked potentials (SEP) and neuron specific enolase (NSE).

  At day-28

Eligibility Criteria

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

Study Population

Comatose patients admitted in ICU after resuscitation from cardiac arrest

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (5)

Brest University Hospital

Brest, Brittany Region, 29609, France

RECRUITING

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Marseille University Hospital

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

RECRUITING

Ambroise Paré - Hartmann Private Hospital Group

Neuilly-sur-Seine, Île-de-France Region, 92200, France

RECRUITING

Cochin Hospital

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Sarah BENGHANEM, MD

CONTACT

01 58 41 25 33; sarah.benghanem@aphp.fr

Bertrand HERMANN, MD, PhD

CONTACT

bertrand.hermann@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)