Transcriptome Assessment After Cardiac Arrest (OMECARD)

" Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " 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.

Study Overview

• Status: Completed
• Conditions: Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
• Intervention / Treatment: Biological: blood sampling

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75005
    • Hôpital Cochin, Assistance Publique Hôpitaux de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 0
Pittsburgh Cerebral Performance Category at Day 60	Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60	Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1
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	Day 3
Pittsburgh Cerebral Performance Category at Day 28	Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28	day 28
Number of participants with death at day 28		day 28
Number of participants with death at day 60		day 60

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; National Research Agency, France; University of Paris 5 - Rene Descartes; Université Paris Est Créteil; Ecole Nationale Vétérinaire d'Alfort
• Investigators: Principal Investigator: Alain Cariou, Prof., Assistance Publique - Hôpitaux de Paris; Study Chair: Renaud Tissier, Prof, Ecole Nationale Vétérinaire d'Alfort

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 24, 2020
• Primary Completion (ACTUAL): February 10, 2022
• Study Completion (ACTUAL): February 10, 2022

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (ACTUAL): March 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: biomarker; cardiac arrest; sequencing; Transcriptome; prognostication; messenger ribonucleic acid (mRNA); successful resuscitation
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: 2019-A00239-48 (REGISTRY: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No