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

NCT06044922 | Recruiting

• 1 other identifier: 2022/01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Cardiac Arrest

Keywords

Heart rate variability; Neurologic prognosis

Outcome Measures

Primary Outcomes (1)

• 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.

  At day-28

Secondary Outcomes (3)

• Net reclassification index

  At day-28

• Brain death

  At day-28

• Days without limitation of life sustaining treatment

  At day-28

Study Arms (1)

Post-cardiac arrest patients

Device: 24-hour Holter monitoring

Interventions

24-hour Holter monitoring DEVICE

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

Post-cardiac arrest patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Comatose patients admitted in ICU after resuscitation from cardiac arrest

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CMC Ambroise Paré: lead

Study Sites (5)

Brest University Hospital

Brest, Brittany Region, 29609, France

RECRUITING

Nantes University Hospital

Nantes, Pays de la Loire Region, 44093, France

RECRUITING

Marseille University Hospital

Marseille, Provence-Alpes-Côte d'Azur Region, 13005, France

RECRUITING

Ambroise Paré - Hartmann Private Hospital Group

Neuilly-sur-Seine, Île-de-France Region, 92200, France

RECRUITING

Cochin Hospital

Paris, Île-de-France Region, 75014, France

RECRUITING

MeSH Terms

Conditions

Heart Arrest

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Central Study Contacts

Guillaume GERI, MD, PhD

CONTACT

0146415079; guillaume.geri@clinique-a-pare.fr

Cécile NAUDIN, PhD

CONTACT

cecile.naudin@clinique-a-pare.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: October 23, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)