NCT03539497

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

March 24, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
7 months until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

4.6 years

First QC Date

March 24, 2018

Last Update Submit

December 5, 2023

Conditions

Cardiac Arrest

Keywords

biomarker

Outcome Measures

Primary Outcomes (1)

  • Correlation of plasma mitochondrial DNA and cytochrome C with survival with good neurological outcome (CPC 1 and 2) at hospital discharge

    Relationship between plasma mitochondrial DNA and cytochrome C with neurological damage after cardiac arrest

    In hospital mortality, 30days

Interventions

BiomarkerDIAGNOSTIC_TEST

Plasma mitochondrial DNA, plasma Cytochrome C

Eligibility Criteria

Age14 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Unconscious patients after cardiac arrest treated with therapeutic hypothermia.

You may qualify if:

  • unconscious after cardiac arrest
  • therapeutic hypothermia

You may not qualify if:

  • expected survival less than 24h

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

Location

Related Publications (5)

  • Greer DM, Rosenthal ES, Wu O. Neuroprognostication of hypoxic-ischaemic coma in the therapeutic hypothermia era. Nat Rev Neurol. 2014 Apr;10(4):190-203. doi: 10.1038/nrneurol.2014.36. Epub 2014 Mar 11.

    PMID: 24614515BACKGROUND

  • Girotra S, Chan PS, Bradley SM. Post-resuscitation care following out-of-hospital and in-hospital cardiac arrest. Heart. 2015 Dec;101(24):1943-9. doi: 10.1136/heartjnl-2015-307450. Epub 2015 Sep 18.

    PMID: 26385451BACKGROUND

  • Arnalich F, Codoceo R, Lopez-Collazo E, Montiel C. Circulating cell-free mitochondrial DNA: a better early prognostic marker in patients with out-of-hospital cardiac arrest. Resuscitation. 2012 Jul;83(7):e162-3. doi: 10.1016/j.resuscitation.2012.03.032. Epub 2012 Apr 7. No abstract available.

    PMID: 22490673BACKGROUND

  • Rodrigues Filho EM, Ikuta N, Simon D, Regner AP. Prognostic value of circulating DNA levels in critically ill and trauma patients. Rev Bras Ter Intensiva. 2014 Jul-Sep;26(3):305-12. doi: 10.5935/0103-507x.20140043.

    PMID: 25295826BACKGROUND

  • Nakahira K, Hisata S, Choi AM. The Roles of Mitochondrial Damage-Associated Molecular Patterns in Diseases. Antioxid Redox Signal. 2015 Dec 10;23(17):1329-50. doi: 10.1089/ars.2015.6407. Epub 2015 Aug 17.

    PMID: 26067258BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

mitochondrial DNA

MeSH Terms

Conditions

Heart Arrest

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

BiomarkersBiological FactorsBiological PhenomenaEnvironmental MonitoringEnvironmental ExposureEnvironmental PollutionPublic HealthEnvironment and Public Health

Study Officials

  • Marko Noč, MD

    UMC Ljubljana

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 24, 2018

First Posted

May 29, 2018

Study Start

January 8, 2019

Primary Completion

August 23, 2023

Study Completion

March 30, 2024

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)