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

Sponsor

CMC Ambroise Paré (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06044922

Collaborator

(none)

200

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Device: 24-hour Holter monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2026

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Post-cardiac arrest patients	Device: 24-hour Holter monitoring Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording

Arm

Intervention/Treatment

Post-cardiac arrest patients

Device: 24-hour Holter monitoring

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

Outcome Measures

Primary Outcome Measures

Poor neurological outcome evaluated using the CPC score [At day-28]
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.

Secondary Outcome Measures

Net reclassification index [At day-28]
Brain death [At day-28]
Days without limitation of life sustaining treatment [At day-28]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brest University Hospital	Brest	Bretagne	France	29609
2	Ambroise Paré - Hartmann Private Hospital Group	Neuilly-sur-Seine	Ile-de-France	France	92200
3	Cochin Hospital	Paris	Ile-de-France	France	92200
4	Nantes University Hospital	Nantes	Pays De La Loire	France	44093
5	Marseille University Hospital	Marseille	Provence-Alpes-Côte d'Azur	France	13005

Sponsors and Collaborators

CMC Ambroise Paré

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CMC Ambroise Paré

ClinicalTrials.gov Identifier:

NCT06044922

Other Study ID Numbers:

2022/01

First Posted:

Sep 21, 2023

Last Update Posted:

Sep 21, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by CMC Ambroise Paré

Heart rate variability

Neurologic prognosis

Additional relevant MeSH terms:

Brain Injuries

Heart Arrest

Study Results

No Results Posted as of Sep 21, 2023