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NCT Number: NCT07464938

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, 1200, Belgium

Location status: Recruiting

Location contact

Pasquale Scoppettuolo, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

  1. Neurological outcome

    Time frame: Throughout the entire study, approximately during 2 years

    The 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 outcomes

  1. Proteomics-based serum alteration (thrombosis and inflammation panel)

    Time frame: Throughout the entire study, approximately during 2 years

    Proteomics-based analysis of serum alterations focusing on thrombosis and inflammation pathways

  2. Cerebral ultrasound parameters and outcome prediction

    Time frame: Throughout the entire study, approximately during 2 years

    Cut-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

  3. ONSD and neurological outcome

    Time frame: Throughout the entire study, approximately during 2 years

    Optic nerve sheath ultrasound (ONSD) cut-off (mm) for unfavourable and favorable outcome/mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Pasquale Scoppettuolo, MD

CONTACT

[email protected]

+3227618176 ext. +3227618176

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Acronym: ARCAPROTEOFLOW

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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