Actively Recruiting
Brain Heart InterActioNs in Cardiac Arrest Ancillary Study of the HEAVENwARd Trial
Led by CMC Ambroise Paré · Updated on 2025-03-27
200
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have experienced cardiac arrest and survived after restoration of spontaneous circulation (ROSC). Despite advances in care, many survivors suffer brain damage ranging from mild cognitive issues to severe vegetative states. This study focuses on exploring the interactions between the brain and heart, particularly how abnormalities in these interactions might predict neurological outcomes after cardiac arrest. The study is an observational ancillary study of the HEAVENwARd trial. The study includes patients admitted to intensive care after cardiac arrest who are in a coma and undergoing routine EEG with ECG lead recordings for neuroprognostication. It evaluates the prevalence and prognostic value of bilateral brain-heart interactions using synchronous EEG and ECG recordings. The main measurement is brain-heart interactions at day 28, with secondary outcomes including neurological outcomes, mortality, and severity of brain injury assessed by multiple markers. Participants will be monitored during their ICU stay with EEG and ECG recordings, and data will be collected to assess brain-heart coupling and neurological status. The research team will review patient outcomes at 28 days, including neurological function and survival. This study aims to improve understanding of brain-heart dysfunction after cardiac arrest and its potential role in predicting patient prognosis.
CONDITIONS
Brief Title
Brain Heart InterActioNs in Cardiac Arrest. Ancillary Study of the HEAVENwARd Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted in intensive care unit (ICU) after resuscitation from cardiac arrest (in-hospital or out-of-hospital)
- Coma with Glasgow score less than 8 after return of spontaneous circulation (ROSC)
- Requires sedation and targeted temperature management for at least 24 hours
- EEG with ECG lead performed in routine care
You will not qualify if you...
- Patient is dying with limitation of life support techniques at ICU admission
- Limitation of life sustaining treatment before EEG
- Non-sinus heart rhythm
- Pregnant or breastfeeding women
- Patient under adult protection (guardianship, curatorship, or safeguard of justice)
- Opposition by the trusted person or by the patient
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Within the first days after ICU admission
Participants undergo EEG with ECG lead recording as part of routine care for neuroprognostication after cardiac arrest.
1 visit (in-person)
Duration - Up to 28 days
Participants are observed for neurological outcomes, mortality, and brain-heart interaction markers up to 28 days after cardiac arrest.
Assessments during ICU stay and follow-up until day 28
Trial Site Locations
Total: 5 locations
1
Brest University Hospital
Brest, Brittany Region, France, 29609
Actively Recruiting
2
Nantes University Hospital
Nantes, Pays de la Loire Region, France, 44093
Actively Recruiting
3
Marseille University Hospital
Marseille, Provence-Alpes-Côte d'Azur Region, France, 13005
Actively Recruiting
4
Ambroise Paré - Hartmann Private Hospital Group
Neuilly-sur-Seine, Île-de-France Region, France, 92200
Actively Recruiting
5
Cochin Hospital
Paris, Île-de-France Region, France, 75014
Actively Recruiting
Research Team
S
Sarah BENGHANEM, MD
B
Bertrand HERMANN, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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