- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481396
Molecular Insights Into Post-Cardiac Arrest Brain Injury Via CSF Multi-Omics (PCABI-OMICS)
Identification of Novel Molecular Pathophysiological Mechanisms of Secondary Brain Injury in Post-cardiac Arrest Syndrome Patients Using Cerebrospinal Fluid Multi-omics Analysis
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Changshin Kang, MD. PhD
- Phone Number: +821089928386
- Email: rosc@cnu.ac.kr
Study Locations
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Jung-gu
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Daejeon, Jung-gu, South Korea, 35015
- Recruiting
- Chungnam National University Hospital
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Contact:
- Jiyoung Choi
- Phone Number: +82-42-280-6713
- Email: rosc@cnu.ac.kr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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)
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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)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Neurological outcome
Time Frame: at discharge (assessed up to 3 days), 3 months after return of spontaneous circulation (ROSC)
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Neurological outcome assessed using the Cerebral Performance Category (CPC) scale (range 1-5; lower scores indicate better neurological function).
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at discharge (assessed up to 3 days), 3 months after return of spontaneous circulation (ROSC)
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Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 4. Buunk G, van der Hoeven JG, Meinders AE. Cerebral blood flow after cardiac arrest. Neth J Med 2000;57:106-12.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Heart Diseases
- Brain Ischemia
- Signs and Symptoms, Respiratory
- Hypoxia, Brain
- Hypoxia
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Heart Arrest
- Hypoxia-Ischemia, Brain
Other Study ID Numbers
- CNUH-2025-07-044-003
- RS-2025-00554697 (Other Grant/Funding Number: National Research Foundation of Korea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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