Actively Recruiting

Age: 18Years +
All Genders
NCT06327334

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

Led by CMC Ambroise Paré · Updated on 2025-03-27

200

Participants Needed

5

Research Sites

159 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
  • Coma (Glasgow score < 8) after return of spontaneous circulation (ROSC), requiring sedation and targeted temperature management for at least 24 hours
  • EEG with ECG lead performed in routine care
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

Brest University Hospital

Brest, Brittany Region, France, 29609

Actively Recruiting

2

Nantes University Hospital

Nantes, Pays de la Loire Region, France, 44093

Actively Recruiting

3

Marseille University Hospital

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

Actively Recruiting

4

Ambroise Paré - Hartmann Private Hospital Group

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

Actively Recruiting

5

Cochin Hospital

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

Actively Recruiting

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Research Team

S

Sarah BENGHANEM, MD

CONTACT

B

Bertrand HERMANN, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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