Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest (HEAVENwARd)

December 11, 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.

Early prognostication in comatose patients after ROSC remains challenging. Recent recommendations suggest carrying out clinical and paraclinical tests during the first 72 h after ROSC, to predict a poor neurological outcome with a specificity greater than 95% (no pupillary and corneal reflexes, bilaterally absent N20 somatosensory evoked potential wave, status myoclonus, highly malignant electroencephalography including suppressed background ± periodic discharges or burst-suppression, neuron-specific enolase (NSE) > 60 µg/L, a diffuse and extensive anoxic injury on brain CT/MRI), but with a low sensitivity due to frequent confounding factors.

The heart rate variability (HRV) is a simple and non-invasive technique for assessing the autonomic nervous system function. In patients with a recent myocardial infarction, reduced HRV is associated with an increased risk for malignant arrhythmias or death. In neurology, reduced HRV is associated with a poor outcome in severe brain injury patients and allows to predict early neurological deterioration and recurrent ischemic stroke after acute ischemic stroke.

A reduced HRV could be a sensitive, specific and early indicator of diffuse anoxic brain injury after CA.

This multicenter prospective cohort study assesses the added value of early HRV (within 24h of ICU admission) for neuroprognostication after cardiac arrest.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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
    • Ile-de-France
      • Neuilly-sur-Seine, Ile-de-France, France, 92200
        • Recruiting
        • Ambroise Paré - Hartmann Private Hospital Group
        • Contact:
        • Contact:
          • Guillaume GERI, MD, PhD
      • Paris, Ile-de-France, France, 75014
        • Recruiting
        • Cochin Hospital
        • Contact:
        • Contact:
          • 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
        • Recruiting
        • Marseille University hospital
        • Contact:
        • Contact:
          • Jeremy BOURENNE, MD

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

Exclusion Criteria:

  • Dying patient (Limitation of life support techniques at admission to the ICU)
  • 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 once he/she wakes up

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-cardiac arrest patients
Device: 24-hour Holter monitoring
Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording

What is the study measuring?

Primary 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

Secondary Outcome Measures

Outcome Measure
Time Frame
Net reclassification index
Time Frame: At day-28
At day-28
Brain death
Time Frame: At day-28
At day-28
Days without limitation of life sustaining treatment
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 (Actual)

October 23, 2024

Primary Completion (Estimated)

December 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 11, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/01

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

product manufactured in and exported from the U.S.

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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