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

Cardiac Arrest Clinical Trial

— HEAVENwARd  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06044922
• Other study ID #: 2022/01
• Status: Not yet recruiting
• Start date: April 15, 2024
• Est. completion date: May 15, 2027

Study information

• Verified date: January 2024
• Source: CMC Ambroise Paré
• Contact: Guillaume GERI, MD, PhD
• Phone: 0146415079
• Email: guillaume.geri[@]clinique-a-pare.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Cardiac Arrest
• Heart Arrest

Intervention

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

Locations

Country	Name	City	State
France	Brest University Hospital	Brest	Bretagne
France	Marseille University Hospital	Marseille	Provence-Alpes-Côte d'Azur
France	Nantes University Hospital	Nantes	Pays De La Loire
France	Ambroise Paré - Hartmann Private Hospital Group	Neuilly-sur-Seine	Ile-de-France
France	Cochin Hospital	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Net reclassification index		At day-28
Secondary	Brain death		At day-28
Secondary	Days without limitation of life sustaining treatment		At day-28