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Completed

NCT Number: NCT03895736

Transcriptome Assessment After Cardiac Arrest

The purpose of this study is to determine whether the blood transcriptome of patients resuscitated after out-of-hospital could be an early predictor of the neurological outcome.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Cochin, Assistance Publique Hôpitaux de Paris

Paris, 75005, France

About this study

Assessing the prognosis of the patients resuscitated after out-of-hospital cardiac arrest (OHCA) is still highly challenging. Beyond usual neurological markers, experimental and clinical studies have also shown that blood levels of several cytokines or miRNA could be significantly different after cardiac arrest in subjects prematurely died as compared to survivors with a good neurological recovery. Here the investigators propose to investigate a screening approach assessing simultaneously multiple targets of the post-cardiac arrest syndrome through analysis of the whole transcriptome of patients after OHCA. For this purpose, the investigators will collect blood samples from 60 patients after admission at hospital and then 1 and 3 days later. The Pittsburgh Cerebral Performance Category of each patient will be evaluated for each patient at day 60 after cardiac arrest. At the end of the collection period, the blood samples will be prepared for whole genome analysis and RNA sequencing. The primary analysis of the investigators will be the comparison of the transcriptome at day 0 after cardiac arrest in patients reaching Cerebral Performance Category (CPC) 1 at day 60 as compared to all other patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 80 years
  • Delay between patients collapse and resumption of spontaneous circulation (ROSC) < 60 minutes
  • Comatose patients ROSC with Glasgow score < 7
  • Patient already registered in the social security system
  • Consent of a family member, if able to understand in the emergency context, or attestation of emergency situation with a follow-up information notice

Exclusion criteria

  • Cardiac arrest supposed to be provoked by trauma or sepsis

Treatment and study plan

Blood sampling

Biological

Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3

Other names: Blood sampling at Day 0, Day 1 and Day 3

Primary outcomes

  1. Early Transcriptome at hospital admission

    Time frame: Day 0

    Blood samples will be collected for each patient early after admission at hospital and blood whole transcriptome will be assessed by RNA sequencing

  2. Pittsburgh Cerebral Performance Category at Day 60

    Time frame: Day 60

    Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

Secondary outcomes

  1. Transcriptome at day 1

    Time frame: Day 1

    Blood samples will be collected for each patient at day 1 and blood whole transcriptome will be assessed by RNA sequencing

  2. Transcriptome at day 3

    Time frame: Day 3

    Blood samples will be collected for each patient at day 3 and blood whole transcriptome will be assessed by RNA sequencing

  3. Pittsburgh Cerebral Performance Category at Day 28

    Time frame: day 28

    Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28

  4. Number of participants with death at day 28

    Time frame: day 28

  5. Number of participants with death at day 60

    Time frame: day 60

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Ecole Nationale Vétérinaire d'Alfort
  • Institut National de la Santé Et de la Recherche Médicale, France
  • National Research Agency, France
  • Paris 12 Val de Marne University
  • URC-CIC Paris Descartes Necker Cochin
  • University of Paris 5 - Rene Descartes

Registry information

Official study title

" Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " Transcriptome Assessment After Cardiac Arrest

Acronym: OMECARD

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Mar 29, 2019
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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