Clinical trial NCT03895736: Transcriptome Assessment After Cardiac Arrest
Official title: " Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " Transcriptome Assessment After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
Keywords: Transcriptome
messenger ribonucleic acid (mRNA)
sequencing
biomarker
cardiac arrest
prognostication
successful resuscitation
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
name: University of Paris 5 - Rene Descartes
name: Institut National de la Santé Et de la Recherche Médicale, France
name: Paris 12 Val de Marne University
name: Ecole Nationale Vétérinaire d'Alfort
First posted: 2019-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Early Transcriptome at hospital admission
timeFrame: Day 0
measure: Pittsburgh Cerebral Performance Category at Day 60
timeFrame: Day 60
Secondary outcomes:
measure: Transcriptome at day 1
timeFrame: Day 1
measure: Transcriptome at day 3
timeFrame: Day 3
measure: Pittsburgh Cerebral Performance Category at Day 28
timeFrame: day 28
measure: Number of participants with death at day 28
timeFrame: day 28
measure: Number of participants with death at day 60
timeFrame: day 60
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin, Assistance Publique Hôpitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alain Cariou, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ecole Nationale Vétérinaire d'Alfort
name: Renaud Tissier, Prof
role: STUDY_CHAIR
References: