Cardiac Arrest (CA)CINEFILNCT07760636
Kinetics and Prognostic Value of NeuroFilament Light in Post-cardiac Arrest: A Prospective Multicenter Study
An observational study of Cardiac Arrest (CA) and Intensive Care Unit (ICU) Admission, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to assess the prognostic value of absolute value and kinetic of neurofilament light chain (NFL) collected at different time points (at admission, 12h, 24h, 48h, 72h, 96h, and day 7 after ICU admission) in predicting poor and good neurological outcome in comatose patients after cardiac… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest (CA), Intensive Care Unit (ICU) Admission, Return of Spontaneous Circulation
- What is being tested?
- Value of neurofilament light chain (NFL) at different time points
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Jun 2028
- Phase
- Observational
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 after cardiac arrest
Who may be able to join
- Patients admitted to the ICU for cardiac arrest,
- Patients who regained consciousness following in-hospital or out-of-hospital cardiac arrest,
- Patients in a coma upon arrival in the ICU, defined by a Glasgow Coma Scale (GCS) score <8,
- Patients included in the AfterROSC2 cohort,
Who cannot join
- Terminally ill patients (death expected within 3 hours of admission to the ICU),
- Minors,
- Patients under legal guardianship,
- Pregnant women,
- Patients not enrolled in a social security program,
- Prior inclusion in the CINEFIL study,
- Restriction of active therapies prior to the first NFL biomarker assay,
- Objection by a family member or trusted person, if present
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Medical ICU
Paris, IDF, 75014
Sarah Benhganem, 00331 58 41 43 35, sarah.benghanem@aphp.fr
About this study
The purpose of this study is to assess the prognostic value of absolute value and kinetic of neurofilament light chain (NFL) collected at different time points (at admission, 12h, 24h, 48h, 72h, 96h, and day 7 after ICU admission) in predicting poor and good neurological outcome in comatose patients after cardiac arrest.
Read the detailed description
A large majority of patients resuscitated after cardiac arrest (CA) are comatose following the return of spontaneous circulation and require admission to the intensive care unit (ICU). Unfortunately, many of them die during their ICU stay, mainly following the decision to withdraw life-sustaining therapies due to ischemic and hypoxic brain injuries considered irreversible. Early identification of these neurological injury is therefore one of the major challenges for intensivists, in order to tailor the intensity of care.
Currently, the recommended strategy consists of applying a multimodal prognostic approach. This algorithm allows prediction of poor neurological outcome in approximately 50% of cases, according to various studies. This highlights the need for new early prognostic markers to predict both unfavorable and favorable outcomes.
Regarding biomarkers of brain injury, European guidelines recommend the measurement of serum NSE, a biomarker of neuronal injury that is now commonly used. An NSE level > 60 µg/L at 48 and/or 72 hours after cardiac arrest predicts poor neurological outcome with good accuracy (AUC between 0.80 and 0.92 depending on the study), high specificity but limited sensitivity. Moreover, uncertainty remains regarding the optimal threshold value to use, and variable results have been reported across clinical studies. Finally, early serum NSE levels (within the first 24-48 hours) have limited prognostic value, which restricts their usefulness for the early identification of patients likely to have a poor outcome. These limitations have highlighted the need to identify new biomarkers of brain injury to better assess the prognosis of these patients.
- Conditions
- Cardiac Arrest (CA), Intensive Care Unit (ICU) Admission, Return of Spontaneous Circulation, Comatose
- Being tested
- Value of neurofilament light chain (NFL) at different time points
- Keywords
- Cardiac arrest, Coma, Neuroprognostication, Biomarkers, Neurofilament light chain
- Medical subject headings
- Heart Arrest, Coma, Charcot-Marie-Tooth disease, Type 1F
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Value of neurofilament light chain (NFL) at different time pointsOther
Value of neurofilament light chain (NFL) at different time points (H0, H12, H24, H48, H72, H96, and day 7 after ICU admission
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients Receives: Other: Value of neurofilament light chain (NFL) at different time points |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale (mRS)
Neurological outcome assessed by the modified Rankin Scale (mRS) (An unfavorable outcome is defined as a modified Rankin Scale (mRS) score between 4 and 6 (severe neurological sequelae, persistent coma, or death), and a favorable outcome as a modified Rankin Scale (mRS) score between 0 and 3 (no sequelae, mild to moderate neurological sequelae))
Measured: 3 months
Secondary outcomes (8)
Mortality
Measured: At ICU discharge, up to 3 months
Early myoclonus
Clinical, imaging, or neurophysiological neurological abnormalities :
early myoclonus (<72 hours)
Measured: <72 hours
Myoclonus status
Clinical, imaging, or neurophysiological neurological abnormalities:
myoclonus status (<72 hours post-CA)
Measured: <72 hours post-CA
Pupillary and corneal reflexes
Clinical, imaging, or neurophysiological neurological abnormalities:
pupillary and corneal reflexes at 72 hours post-CA
Measured: 72 hours post-CA
Pupillary and corneal reflexes
Clinical, imaging, or neurophysiological neurological abnormalities:
brain imaging, if performed
Measured: 3 months
Electroencephalogram (EEG)
Neurological abnormalities
Measured: 3 months
Somatosensory evoked potentials
Neurological abnormalities
Measured: 3 months
Auditory evoked potentials
Neurological abnormalities
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Arrest (CA)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Benghanem, Principal investigator, Medical ICU, Cochin hospital, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760636
- Sponsor's protocol ID
- APHP251892 - CINEFIL
- Other IDs
- 2025-A02758-41
- Acronym
- CINEFIL
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided