An observational study in Cardiac Arrest, sponsored by CMC Ambroise Paré. Recruiting at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by CMC Ambroise Paré · Observational
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.
926 studies on the registry are indexed under Heart Arrest; 226 are open to participants now.
This study's planned enrollment of 200 is close to the median of 200 across 376 observational studies indexed under Heart Arrest.
Browse Heart Arrest studies →CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
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Comatose patients admitted in ICU after resuscitation from cardiac arrest
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Exclusion Criteria:
Device: 24-hour Holter monitoring
Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording
Poor neurological outcome evaluated using the CPC score
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.
Time frame: At day-28
Net reclassification index
Time frame: At day-28
Brain death
Time frame: At day-28
Days without limitation of life sustaining treatment
Time frame: At day-28
Plan to share: No
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CMC Ambroise Paré