Cardiac ArrestHEAVENwARdNCT06044922
Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
An observational study of Cardiac Arrest, run by CMC Ambroise Paré at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- 24-hour Holter monitoring
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- 23 Oct 2024to 15 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Comatose patients admitted in ICU after resuscitation from cardiac arrest
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cécile NAUDIN, PhD contact
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Brest University Hospital
Brest, Brittany Region, 29609
Pierre BAILLY, MD, pierre.bailly@chu-brest.fr
Pierre BAILLY, MD
- Recruiting
Marseille University Hospital
Marseille, Provence-Alpes-Côte d'Azur Region, 13005
Jeremy BOURENNE, MD, jeremy.bourenne@ap-hm.fr
Jeremy BOURENNE, MD
- Recruiting
Nantes University Hospital
Nantes, Pays de la Loire Region, 44093
Jean-Baptiste LASCARROU, MD, jeanbaptiste.lascarrou@chu-nantes.fr
Jean-Baptiste LASCARROU, MD
- Recruiting
Ambroise Paré - Hartmann Private Hospital Group
Neuilly-sur-Seine, Île-de-France Region, 92200
Guillaume GERI, MD, PhD, guillaume.geri@clinique-a-pare.fr
Guillaume GERI, MD, PhD
- Recruiting
Cochin Hospital
Paris, Île-de-France Region, 75014
Alain CARIOU, MD, PhD, alain.cariou@aphp.fr
Alain CARIOU, MD, PhD
About this study
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.
Read more
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
- Being tested
- 24-hour Holter monitoring
- Keywords
- Heart rate variability, Neurologic prognosis
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hour Holter monitoringDevice
Holter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording
| Study group | Role | What they receive |
|---|---|---|
| Post-cardiac arrest patients | Not described Receives: Device: 24-hour Holter monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day-28
Secondary outcomes (3)
Net reclassification index
Measured: At day-28
Brain death
Measured: At day-28
Days without limitation of life sustaining treatment
Measured: At day-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start23 Oct 2024
- Primary completion15 Dec 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044922
- Sponsor's protocol ID
- 2022/01
- Acronym
- HEAVENwARd
- Status last verified
- Dec 2024
- First submitted
- 13 Sep 2023
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability in Early Prediction of a Noxic Brain Injury After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT06044922
- Acronym / sponsor ID
- HEAVENwARd / 2022/01
- Conditions
- Cardiac Arrest
- Keywords
- Heart rate variability, Neurologic prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 23 Oct 2024 (actual)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-cardiac arrest patients | – | Device: 24-hour Holter monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Comatose patients admitted in ICU after resuscitation from cardiac arrest
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24-hour Holter monitoringHolter monitor is fitted within 2h of ICU admission to acquire a 24-hour electrocardiogram recording | Device | Post-cardiac arrest patients |
Primary outcome
Poor neurological outcome evaluated using the CPC score
Time frame: 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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cécile NAUDIN, PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest, run by CMC Ambroise Paré at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume GERI, MD, PhD (0146415079 ext. +33, guillaume.geri@clinique-a-pare.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Poor neurological outcome evaluated using the CPC score (time frame: At day-28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.