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NCT Number: NCT06044922

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Brest University Hospital, Brest, Brittany Region, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24-hour Holter monitoring

Device

Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording

Primary outcomes

  1. 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.

Secondary outcomes

  1. Net reclassification index

    Time frame: At day-28

  2. Brain death

    Time frame: At day-28

  3. Days without limitation of life sustaining treatment

    Time frame: At day-28

Study contacts

Contact information is provided by the study sponsor or research team.

Cécile NAUDIN, PhD

CONTACT

[email protected]

Guillaume GERI, MD, PhD

CONTACT

[email protected]

0146415079 ext. +33

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: HEAVENwARd

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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