NCT07090577

Brief Summary

The goal of this observational study is to identify further pathophysiologic mechanism of secondary brain injury following cardiac arrest by using serial multiomics profiling of serum and cerebrospinal fluid (CSF) samples. The main question it aims to answer is: A. The main question it aims to answer is: What are the dynamic molecular changes in serum and CSF that reflect the pathophysiological mechanisms of secondary brain injury after cardiac arrest? B. What are the differences in serum and CSF multiomic signatures between varying severities of cardiac arrest, and how are these differences associated with the underlying pathophysiological mechanisms of secondary brain injury? Serum and CSF samples that have already been prospectively collected from participants and stored in the BioBank will be used for this analysis.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jul 2025Dec 2026

First Submitted

Initial submission to the registry

July 21, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

1.4 years

First QC Date

July 21, 2025

Last Update Submit

July 21, 2025

Conditions

Keywords

cardiac arresthypoxic-ischemic brain injurypost-resuscitation syndromemultiomicscerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome

    Cerebral Performance Category (CPC) score

    after 6 months from return of spontaneous circulation

Secondary Outcomes (1)

  • The Pittsburgh Cardiac Arrest Category (PCAC)

    immediately after return of spontaneous circulation

Study Arms (2)

good neurologic outcome

Cerebral Performance Category (CPC) : 1 or 2

poor neurologic outcome

Cerebral Performance Category (CPC) : 3 to 5

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with an out-of-hospital cardiac arrest who underwent post-resuscitation care

You may qualify if:

  • Age ≥ 18 years old
  • Out-of-hospital cardiac arrest (OHCA)
  • Patients who have received post-resuscitation care including temperature control due to unconsciousness (Glasgow Coma Score \< 8) after sustained ROSC.
  • Patients who consented to the placement of lumbar catheter for storing cerebrospinal fluid and blood samples in a human biobank.

You may not qualify if:

  • Patients diagnosed with a central nervous system-related disease before cardiac arrest
  • Patients who have undergone extracorporeal circulatory membrane oxygenation therapy
  • Patients who died within 24 hours from post-resuscitation care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Related Publications (3)

  • You Y, Park JS, Min JH, Jeong W, Ahn HJ, In YN, Jeon SY, Lee JK, Kang C. Blood-brain barrier permeability for the first 24 hours in hypoxic-ischemic brain injury following cardiac arrest. Resuscitation. 2024 May;198:110150. doi: 10.1016/j.resuscitation.2024.110150. Epub 2024 Feb 23.

    PMID: 38401708BACKGROUND
  • Stopa V, Lileikyte G, Bakochi A, Agarwal P, Beske R, Stammet P, Hassager C, Arman F, Nielsen N, Devaux Y. Multiomic biomarkers after cardiac arrest. Intensive Care Med Exp. 2024 Sep 27;12(1):83. doi: 10.1186/s40635-024-00675-y.

    PMID: 39331333BACKGROUND
  • Lileikyte G, Bakochi A, Ali A, Moseby-Knappe M, Cronberg T, Friberg H, Lilja G, Levin H, Arman F, Kjellstrom S, Dankiewicz J, Hassager C, Malmstrom J, Nielsen N. Serum proteome profiles in patients treated with targeted temperature management after out-of-hospital cardiac arrest. Intensive Care Med Exp. 2023 Jul 17;11(1):43. doi: 10.1186/s40635-023-00528-0.

    PMID: 37455296BACKGROUND

MeSH Terms

Conditions

Heart ArrestHypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

July 22, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared publicly due to ethical and privacy concerns. However, data sharing may be possible upon reasonable request with prior approval from the ethics committee and the principal investigator

Locations