NCT06044922 Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
| NCT ID | NCT06044922 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CMC Ambroise Paré |
| Condition | Cardiac Arrest |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-10-23 |
| Primary Completion | 2027-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2024-10-23 with a primary completion date of 2027-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06044922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cardiac Arrest. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06044922 currently recruiting?
Yes, NCT06044922 is actively recruiting participants. Contact the research team at guillaume.geri@clinique-a-pare.fr for enrollment information.
Where is the NCT06044922 trial being conducted?
This trial is being conducted at Brest, France, Nantes, France, Marseille, France, Neuilly-sur-Seine, France and 1 additional location.
Who is sponsoring the NCT06044922 clinical trial?
NCT06044922 is sponsored by CMC Ambroise Paré. The trial plans to enroll 200 participants.