NCT07481396

Brief Summary

The goal of this study is to uncover the molecular mechanisms responsible for secondary brain injury in patients with post-cardiac arrest syndrome by analyzing cerebrospinal fluid (CSF) using multi-omics techniques. The main question this study aims to answer is: Which genome-, transcriptome-, proteome-, and metabolome-level changes in CSF are associated with secondary brain injury after cardiac arrest? To address this question, CSF samples collected from post-cardiac arrest patients will undergo multi-omics analyses. Identified molecular pathways will be used to screen existing drug databases and generate new therapeutic candidates through computational modeling and compound synthesis. These findings will provide the scientific foundation needed to design and implement future preclinical experiments using cardiac arrest animal models.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
20mo left

Started Dec 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
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 Progress24%
Dec 2025Feb 2028

First Submitted

Initial submission to the registry

November 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

November 27, 2025

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome

    Neurological outcome assessed using the Cerebral Performance Category (CPC) scale (range 1-5; lower scores indicate better neurological function).

    at discharge (assessed up to 3 days), 3 months after return of spontaneous circulation (ROSC)

Study Arms (2)

Favorable neurological outcome

The favorable neurological outcome group is classified as patients with a CPC score of 1 or 2 upon long-term follow-up (at discharge, 3 months after post-resuscitation)

Unfavorable neurological outcome

The favorable neurological outcome group is classified as patients with a CPC score of 3 to 5 upon long-term follow-up (at discharge, 3 months after post-resuscitation)

Eligibility Criteria

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

The study population for this research consists of a highly specific and clinically critical group of patients: Adults who have experienced out-of-hospital or in-hospital cardiac arrest and successfully regained spontaneous circulation (ROSC), but remain at high risk for secondary brain injury.

You may qualify if:

  • Patients receiving post-resuscitation care after out-of-hospital cardiac arrest for secondary brain injury treatment.
  • Patients without contraindications for lumbar puncture catheter insertion for cerebrospinal fluid (CSF) collection. This includes the absence of:
  • Uncontrolled diabetes.Coagulation disorders.
  • Thrombocytopenia (platelet count $\< 100,000).
  • A history of cirrhosis diagnosis.
  • Current receipt of low molecular weight heparin.
  • Current use of platelet inhibitors.
  • A history of posterior spinal fusion that may interfere with catheter insertion.
  • Local skin infection or rash at the puncture site.
  • Signs of systemic infection or sepsis.
  • A history of lumbar puncture within the past 6 hours.

You may not qualify if:

  • Cerebral Edema: Patients with evidence of cerebral edema on a brain computed tomography (CT) scan performed immediately after spontaneous circulation recovery.
  • Patients who underwent extracorporeal membrane oxygenation (ECMO).
  • Patients who could not maintain integrated therapy for more than 24 hours after cardiac arrest.
  • Patients with a history of acute or chronic brain disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University Hospital

Daejeon, Jung-gu, 35015, South Korea

RECRUITING

Related Publications (4)

  • 5. Edgren E, Enblad P, Grenvik A, et al. Cerebral blood flow and metabolism after cardiopulmonary resuscitation. A pathophysiologic and prognostic positron emission tomography pilot study. Resuscitation 2003;57:161-70.

    BACKGROUND
  • 4. Buunk G, van der Hoeven JG, Meinders AE. Cerebral blood flow after cardiac arrest. Neth J Med 2000;57:106-12.

    BACKGROUND
  • Madl C, Holzer M. Brain function after resuscitation from cardiac arrest. Curr Opin Crit Care. 2004 Jun;10(3):213-7. doi: 10.1097/01.ccx.0000127542.32890.fa.

    PMID: 15166839BACKGROUND
  • 1. Wiklund LM, Miclescu A, Semenas E, Rubertsson S, Sharma HS. Central nervoustissue damage after hypoxia and reperfusion in conjunction with cardiac arrest and cardiopulmonary resuscitation: mechanisms of action and possibilities for mitigation. Int Rev Neruobiol 2012;102:173-87.

    BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

The primary and exclusive biological sample collected and retained for the multi-omics analysis is the cerebrospinal fluid and serum.

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

Central Study Contacts

Changshin Kang, MD. PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

November 27, 2025

First Posted

March 18, 2026

Study Start

December 1, 2025

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

February 28, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations