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New Tools and Predictive Markers in the Prognosis of Hypoxic-ischemic Encephalopathy Following Cardiac Arrest

New Tools and Predictive Markers in the Prognosis of Hypoxic-ischemic Encephalopathy Following Cardiac Arrest

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07464938
Acronym
ARCAPROTEOFLOW
Enrollment
50
Registered
2026-03-11
Start date
2026-03-23
Completion date
2028-04-01
Last updated
2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest (CA)

Keywords

cardiac arrest, proteomic, Cerebral ultrasounds, neuroprognostication

Brief summary

Cardiac arrest (CA) remains a major cause of mortality and long-term neurological disability worldwide. Despite advances in resuscitation, many survivors suffer from post-cardiac syndrome encompassing PCAS brain injury (PCABI), due to primary (ischemic) and secondary (reperfusion) injury, myocardial dysfunction, systemic response, and persistent underlying causes. PCABI plays a critical role in this complex condition, which is characterized by ischemia, inflammation, and microvascular dysfunction.Current methods to predict neurological outcomes are limited, leading to challenges in clinical decision-making and the risk of premature withdrawal of life-sustaining therapies. This study aims to improve prognostication in CA patients by integrating advanced serum biomarker profiling with cerebral ultrasound (CU) techniques. The investigators hypothesize that combining these tools with clinical data will enhance the accuracy of neurological outcome predictions and deepen understanding of PCABI pathophysiology. The investigators will prospectively enroll 50 CA patients admitted to the intensive care unit at Cliniques Universitaires Saint-Luc. Serum proteomics will be performed using the Reveal panel from Olink®, which analyzes over 1,000 proteins involved in inflammation and thrombosis implicated in PCABI. Concurrently, cerebral ultrasound will assess optic nerve sheath diameter (ONSD) and cerebral blood flow velocities (CBFV) at multiple time points post-resuscitation (at admission, on day 1-2 and on day 3-5). These non-invasive bedside measurements may serve as early indicators of elevated intracranial pressure and cerebral hemodynamic abnormalities.The primary endpoint is poor neurological outcome at one month, defined by the Cerebral Performance Category (CPC) scale. Statistical analyses will evaluate the prognostic value of biomarkers and ultrasound parameters individually and in combination with established clinical predictors.This multimodal approach promises to refine prognostic accuracy, improve clinical decision-making, and identify novel therapeutic targets. Ultimately, our findings may lead to improved patient outcomes and guide future multicenter studies for validation and clinical implementation.

Interventions

DIAGNOSTIC_TESTThis study aims to improve prognostication in OHCA patients by integrating advanced serum biomarker profiling with cerebral ultrasound techniques (flow velocities, optic nerve sheath diameter)

Cerebral ultrasound and blood serum samples will be collected at three time points. EEG, SSEP, and clinical examination will be performed as standard of care.

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients 18-year-old with OHCA admitted to our hospital receiving routine care.

Exclusion criteria

* Patients transferred from other hospitals for OHCA management * Patients with pre-existent neurological disease.

Design outcomes

Primary

MeasureTime frameDescription
Neurological outcomeThroughout the entire study, approximately during 2 yearsThe Cerebral Performance Category (CPC) scale assesses neurological outcome after cardiac arrest at 3 months. CPC 1: Good cerebral performance; normal life or mild neurological deficit. CPC 2: Moderate cerebral disability; independent in activities of daily living. CPC 3: Severe cerebral disability; dependent for daily support. CPC 4: Coma or persistent vegetative state. CPC 5: Brain death or death.

Secondary

MeasureTime frameDescription
Proteomics-based serum alteration (thrombosis and inflammation panel)Throughout the entire study, approximately during 2 yearsProteomics-based analysis of serum alterations focusing on thrombosis and inflammation pathways
Cerebral ultrasound parameters and outcome predictionThroughout the entire study, approximately during 2 yearsCut-off for hemodynamic parameters after CA (Peak Sysolic Velocity and End Diastolic Veclocity, cm/s) and the Resistance Index (RI) and Pulsatility Index (PI) are dimensionless Doppler parameters, as they are calculated as ratios of flow velocities, for unfavourable and favorable outcome/mortality
ONSD and neurological outcomeThroughout the entire study, approximately during 2 yearsOptic nerve sheath ultrasound (ONSD) cut-off (mm) for unfavourable and favorable outcome/mortality

Countries

Belgium

Contacts

CONTACTPasquale Scoppettuolo, MD
pasquale.scoppettuolo@saintluc.uclouvain.be+3227618176

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026