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Transcriptome Assessment After Cardiac Arrest (OMECARD)

Primary Purpose

Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sampling
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation focused on measuring Transcriptome, messenger ribonucleic acid (mRNA), sequencing, biomarker, cardiac arrest, prognostication, successful resuscitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Cochin, Assistance Publique Hôpitaux de Paris

Outcomes

Primary Outcome Measures

Early Transcriptome at hospital admission
Blood samples will be collected for each patient early after admission at hospital and blood whole transcriptome will be assessed by RNA sequencing
Pittsburgh Cerebral Performance Category at Day 60
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

Secondary Outcome Measures

Transcriptome at day 1
Blood samples will be collected for each patient at day 1 and blood whole transcriptome will be assessed by RNA sequencing
Transcriptome at day 3
Blood samples will be collected for each patient at day 3 and blood whole transcriptome will be assessed by RNA sequencing
Pittsburgh Cerebral Performance Category at Day 28
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28
Number of participants with death at day 28
Number of participants with death at day 60

Full Information

First Posted
March 21, 2019
Last Updated
September 26, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France, University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France, Université Paris Est Créteil, Ecole Nationale Vétérinaire d'Alfort
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1. Study Identification

Unique Protocol Identification Number
NCT03895736
Brief Title
Transcriptome Assessment After Cardiac Arrest
Acronym
OMECARD
Official Title
" Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " Transcriptome Assessment After Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
National Research Agency, France, University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France, Université Paris Est Créteil, Ecole Nationale Vétérinaire d'Alfort

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
Keywords
Transcriptome, messenger ribonucleic acid (mRNA), sequencing, biomarker, cardiac arrest, prognostication, successful resuscitation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
blood sampling
Other Intervention Name(s)
Blood sampling at Day 0, Day 1 and Day 3
Intervention Description
Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3
Primary Outcome Measure Information:
Title
Early Transcriptome at hospital admission
Description
Blood samples will be collected for each patient early after admission at hospital and blood whole transcriptome will be assessed by RNA sequencing
Time Frame
Day 0
Title
Pittsburgh Cerebral Performance Category at Day 60
Description
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60
Time Frame
Day 60
Secondary Outcome Measure Information:
Title
Transcriptome at day 1
Description
Blood samples will be collected for each patient at day 1 and blood whole transcriptome will be assessed by RNA sequencing
Time Frame
Day 1
Title
Transcriptome at day 3
Description
Blood samples will be collected for each patient at day 3 and blood whole transcriptome will be assessed by RNA sequencing
Time Frame
Day 3
Title
Pittsburgh Cerebral Performance Category at Day 28
Description
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28
Time Frame
day 28
Title
Number of participants with death at day 28
Time Frame
day 28
Title
Number of participants with death at day 60
Time Frame
day 60

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Cariou, Prof.
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Renaud Tissier, Prof
Organizational Affiliation
Ecole Nationale Vétérinaire d'Alfort
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Cochin, Assistance Publique Hôpitaux de Paris
City
Paris
ZIP/Postal Code
75005
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Transcriptome Assessment After Cardiac Arrest

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