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NCT Number: NCT05679739

NEUROprotection Via optimizINg Cerebral Blood Flow afTer cArdiaC arresT (NEURO-INTACT) Study

This single-center proof of concept study aims to assess the efficacy of a blood pressure strategy targeting person- and time-specific cerebral blood flow compared with standard-of-care using neuron-specific enolase as a quantitative biomarker of brain injury. Our central hypothesis is that an individualized blood pressure strategy targeting cerebral perfusion will reduce the extent of brain injury as indicated by changes in levels of neuron-specific enolase from baseline at 72 hours. To test this hypothesis, we will recruit 49 patients to an individualized blood pressure management strategy targeting cerebral blood flow, where optimal blood pressure will be serially calculated by the ICM+ brain monitoring software (Cambridge, UK) using inputs from transcranial Doppler ultrasound and near-infrared spectroscopy.

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Key information

Conditions

Out-Of-Hospital Cardiac Arrest (OHCA) Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Heart Centre, Singapore

Singapore

Location status: Recruiting

Location contact

Shir Lynn Lim

CONTACT

[email protected]

69082222

Shir Lynn Lim

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • At least 21 years of age
  • Comatose defined as not being able to obey verbal commands and no verbal response to pain after sustained ROSC.

Exclusion criteria

  • ≥ 80 years old at time of enrolment
  • Pregnant patients
  • Limitations of care or life support therapy withdrawn within 24 hours of admission

Treatment and study plan

Individualized blood pressure strategy

Other

An individualized blood pressure strategy targeting cerebral blood flow, serially guided by near-infrared spectroscopy and transcranial Doppler ultrasound. Assessments are performed on admission, and at 12, 24 and 48 hours post-ROSC.

Primary outcomes

  1. Mean change in neuron-specific enolase (NSE)

    Time frame: 72 hours post ROSC

    The mean change in concentration of NSE from baseline levels to 72 hours post-ROSC.

Secondary outcomes

  1. Peak concentration of myocardial injury biomarker - High-sensitive troponin (hsTNT)

    Time frame: Within 72hours of ROSC

    Peak concentration of myocardial injury biomarker, High-sensitive troponin (hsTNT) within 72 hours of ROSC

  2. Peak concentration of myocardial injury biomarker - N-terminal pro b-type natriuretic peptide (NT-proBNP)

    Time frame: Within 72hours of ROSC

    Peak concentration of myocardial injury biomarker, N-terminal pro b-type natriuretic peptide (NT-proBNP) within 72 hours of ROSC

  3. Peak concentration of renal function - Creatinine

    Time frame: Within 72hours of ROSC

    Peak concentration of renal function, Creatinine within 72 hours of ROSC

  4. Peak concentration of renal injury biomarker - Proenkephalin A 119-159 (penKID)

    Time frame: Within 72hours of ROSC

    Peak concentration of renal injury biomarker, Proenkephalin A 119-159 (penKID) within 72 hours of ROSC

  5. Peak concentration of renal injury biomarker - Biologically active adrenomedullin (bio-ADM)

    Time frame: Within 72hours of ROSC

    Peak concentration of renal injury biomarker, Biologically active adrenomedullin (bio-ADM) within 72 hours of ROSC

  6. Peak concentration of renal injury biomarker - Tissue inhibitor of metalloproteinases 2 (TIMP2)

    Time frame: Within 72hours of ROSC

    Peak concentration of renal injury biomarker, Tissue inhibitor of metalloproteinases 2 (TIMP2) within 72 hours of ROSC

  7. Peak concentration of renal injury biomarker - Insulin Like Growth Factor Binding Protein 7 (IGFBP7)

    Time frame: Within 72hours of ROSC

    Peak concentration of renal injury biomarker, Insulin Like Growth Factor Binding Protein 7 (IGFBP7) within 72 hours of ROSC

  8. Neurological outcome

    Time frame: Through study completion, average of 12 months post OHCA

    Neurological outcomes measured by Cerebral Performance Category (CPC) scale on hospital discharge, and at 3, 6 and 12 months post OHCA. The CPC purports to assess domains of functioning after cardiopulmonary resuscitation (CPR) with scores ranging from 1 (good cerebral performance/normal life) to 5 (brain death).

  9. Physical function

    Time frame: Through study completion, average of 12 months post OHCA

    Physical function measured by the change of Duke Activity Status Index (DASI) self-reported questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. DASI score is the sum of the questionnaire responses, score of 34 or less means moderate-to-severe complications.

  10. Neurocognitive outcome - Montreal Cognitive Assessment (MOCA)

    Time frame: Through study completion, average of 12 months post OHCA

    Neurocognitive is assessed by Montreal Cognitive Assessment (MOCA, global cognition) on hospital discharge, and at 3, 6 and 12 months post OHCA. Scores on the MOCA from zero to 30, while score of 26 and above is considered normal.

  11. Neuropsychological outcome - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: Through study completion, average of 12 months post OHCA

    Neuropsychological deficits is assessed by the modified local version of Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) on hospital discharge, and at 3, 6 and 12 months post OHCA. Standard scores of 70 and above will classify as average/mild impairment, scores 55 to 69 as moderate impairment and severe impairment for scores less than 55.

  12. Neuropsychological outcome- Depression, Anxiety, and Stress Scale (DASS-21)

    Time frame: Through study completion, average of 12 months post OHCA

    Depression, Anxiety, and Stress Scale (DASS-21) is used to assess neuropsychological outcome on hospital discharge, and at 3, 6 and 12 months post OHCA.

  13. Health-related quality of life

    Time frame: Through study completion, average of 12 months post OHCA

    Health-related quality of life measured by EuroQol-5 Dimension-5 Level (EQ-5D-5L) questionnaire on hospital discharge, and at 3, 6 and 12 months post OHCA. EQ-5D-5L questionnaire consists of 5 dimensions (mobility, self care, usual activities, pain/comfort, anxiety/depression). There are 5 levels in each dimensions. The lowest level means normal which the highest level means extremely severe.

Other outcomes

  1. Exploratory outcome - Digital neurocognitive assessment

    Time frame: Through study completion, average of 12 months post OHCA

    Neurocognitive is assessed by digital neurocognitive assessment on hospital discharge, and at 3, 6 and 12 months post OHCA.

Study contacts

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

Shir Lynn Lim

CONTACT

[email protected]

69082222

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 11, 2023
Registry last updated
May 16, 2025

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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