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Prognostic Value of Plasma Mitochondrial DNA and Cytochrome C After Cardiac Arrest

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ClinicalTrials.gov Identifier: NCT03539497
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : January 9, 2019
Sponsor:
Collaborator:
University of Ljubljana
Information provided by (Responsible Party):
Peter Radsel, University Medical Centre Ljubljana

Brief Summary:

The aim of the study is to determine prognostic value of plasma mitochondrial DNA and cytochrome C after cardiac arrest.

The study will be conducted in three parts:

  1. Determine plasma concentrations of mitochondrial DNA and cytochrome C in healthy population.
  2. Determine release profile of mitochondrial DNA and cytochrome C to plasma after cardiac arrest.
  3. Determine plasma prognostic value of mitochondrial DNA and cytochrome C after cardiac arrest and compare it with established prognostic methods.

Condition or disease Intervention/treatment
Cardiac Arrest Diagnostic Test: Biomarker

Detailed Description:

Scientific background

Cardiac arrest is one of leading causes of mortality in developed world. Survival ranges between 15 and 22%. Patients surviving cardiac arrest can have significant neurological impairment. None of currently available diagnostic methods can detect neurological consequences in early post resuscitation period. Biomarkers (NSE - neuron specific enolase, protein S100, GFAP - glial fibrillary acidic protein), imaging (computer tomography, magnetic resonance imaging) and functional studies (EEG - electro encephalography, SSEP - somatosensory evoked potentials) have all shown only limited prognostic value in predicting survival with good neurological outcome after cardiac arrest.

Mitochondrial damage is one of key mechanisms of postresuscitation dysfunction. Elevated values of mitochondrial damage-associated molecular patterns were already linked to worst survival after cardiac arrest and critical illness.

Mitochondrial damage often results in cell death and mitochondrial damage-associated molecular patterns are released into bloodstream. Mitochondrial damage-associated molecular patterns that can be detected in serum or plasma are: mitochondrial DNA, mitochondrial transcription factor A, N-formyl peptides, succinate, cardiolipin, cytochrome C...

With a more sensitive method of early neuroprognostication after cardiac arrest the limited medical resources could be used more effectively in patients with chance of good neurological recovery.

Aim of the study

The aim of this study is to research the role of mitochondrial damage-associated molecular patterns in patients after cardiac arrest.

  1. Determine normal plasma values of mitochondrial damage-associated molecular patterns in healthy population.
  2. Compare current prognostic procedures of post-resuscitation neurological damage with prognostic value of mitochondrial DNA and cytochrome C in plasma.

Expected results

Due to central role of mitochondria in hypoxic-ischemic tissue damage a greater mitochondrial damage (measured trough release of mitochondrial damage-associated molecular patterns) is expected to have direct correlation with extent of tissue damage (also neurological). Currently published data indicate that patients with higher plasma mitochondrial DNA levels after cardiac arrest have higher mortality. Correlation of mitochondrial damage-associated molecular patterns to extent of neurological damage in survivors of cardiac arrest was not researched yet.

Methods

  1. Measurement of measure mitochondrial damage-associated molecular patterns in healthy population (mitochondrial DNA and cytochrome C).
  2. Determination of releasing profile of mitochondrial DNA and cytochrome C in survivors of cardiac arrest and establishment of best sample collection time.
  3. Calculation of predictive value for survival of cardiac arrest with good neurological outcome for mitochondrial DNA and cytochrome C.

Mitochondrial damage-associated molecular patterns will be measured in samples of plasma. Mitochondrial DNA will be measured using PCR method. Cytochrome C will be measured using ELISA.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Value of Plasma Mitochondrial DNA and Cytochrome C After Cardiac Arrest
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest


Intervention Details:
  • Diagnostic Test: Biomarker
    Plasma mitochondrial DNA, plasma Cytochrome C


Primary Outcome Measures :
  1. Correlation of plasma mitochondrial DNA and cytochrome C with survival with good neurological outcome (CPC 1 and 2) at hospital discharge [ Time Frame: In hospital mortality, 30days ]
    Relationship between plasma mitochondrial DNA and cytochrome C with neurological damage after cardiac arrest


Biospecimen Retention:   Samples With DNA
mitochondrial DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Unconscious patients after cardiac arrest treated with therapeutic hypothermia.
Criteria

Inclusion Criteria:

  • unconscious after cardiac arrest
  • therapeutic hypothermia

Exclusion Criteria:

  • expected survival less than 24h

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539497


Contacts
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Contact: Tomaz Goslar, MD +38615229521 tomaz.goslar@gmail.com
Contact: Peter Radsel, MD +38615229513 pradsel@gmail.com

Locations
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Slovenia
University Medical Centre Ljubljana, Ljubljana, Slovenia Recruiting
Ljubljana, Slovenia, 1000
Contact: Tomaz Goslar, MD, PhD    +38641362280    tomaz.goslar@gmail.com   
Sponsors and Collaborators
University Medical Centre Ljubljana
University of Ljubljana
Investigators
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Study Chair: Marko Noč, MD UMC Ljubljana

Publications:
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Responsible Party: Peter Radsel, Principal investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03539497     History of Changes
Other Study ID Numbers: UKC-KOIIM-c-arrest
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Peter Radsel, University Medical Centre Ljubljana:
biomarker
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases