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

March 22, 2024 updated by: CMC Ambroise Paré

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bretagne
      • Brest, Bretagne, France, 29609
        • Brest University Hospital
        • Contact:
        • Principal Investigator:
          • Pierre BAILLY, MD
    • Ile-de-France
      • Neuilly-sur-Seine, Ile-de-France, France, 92200
        • Ambroise Paré - Hartmann Private Hospital Group
        • Contact:
        • Principal Investigator:
          • Guillaume GERI, MD, PhD
      • Paris, Ile-de-France, France, 75014
        • Cochin Hospital
        • Contact:
        • Principal Investigator:
          • Alain CARIOU, MD, PhD
    • Pays De La Loire
      • Nantes, Pays De La Loire, France, 44093
    • Provence-Alpes-Côte d'Azur
      • Marseille, Provence-Alpes-Côte d'Azur, France, 13005
        • Marseille University Hospital
        • Principal Investigator:
          • Jeremy BOURENNE, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Comatose patients admitted in ICU after resuscitation from cardiac arrest

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral brain-heart interactions
Time Frame: At day-28
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Poor neurological outcome evaluated using the CPC score
Time Frame: At day-28

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.
At day-28
Mortality
Time Frame: At day-28
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
At day-28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CMC Ambroise Paré

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

May 15, 2027

Study Completion (Estimated)

May 15, 2027

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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