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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06044922
Acronym
HEAVENwARd
Enrollment
200
Registered
2023-09-21
Start date
2024-10-23
Completion date
2027-12-15
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest

Keywords

Heart rate variability, Neurologic prognosis

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. 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.

Interventions

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

Sponsors

CMC Ambroise Paré
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Poor neurological outcome evaluated using the CPC scoreAt day-28The 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

MeasureTime frame
Net reclassification indexAt day-28
Brain deathAt day-28
Days without limitation of life sustaining treatmentAt day-28

Countries

France

Contacts

Primary ContactGuillaume GERI, MD, PhD
guillaume.geri@clinique-a-pare.fr0146415079
Backup ContactCécile NAUDIN, PhD
cecile.naudin@clinique-a-pare.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026