Transcriptome Assessment After Cardiac Arrest

Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation Clinical Trial

— OMECARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03895736
• Other study ID #: 2019-A00239-48
• Secondary ID: 2019-A00239-48
• Status: Completed
• Phase: N/A
• Start date: February 24, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: September 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 10, 2022
• Est. primary completion date: February 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Arrest
• Out-of-Hospital Cardiac Arrest
• Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation

Intervention

Biological:
• blood sampling
Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3

Locations

Country	Name	City	State
France	Hôpital Cochin, Assistance Publique Hôpitaux de Paris	Paris

Sponsors (6)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Ecole Nationale Vétérinaire d'Alfort, Institut National de la Santé Et de la Recherche Médicale, France, National Research Agency, France, Université Paris Est Créteil, University of Paris 5 - Rene Descartes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pittsburgh Cerebral Performance Category at Day 60	Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60	Day 60
Secondary	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
Secondary	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
Secondary	Pittsburgh Cerebral Performance Category at Day 28	Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28	day 28
Secondary	Number of participants with death at day 28		day 28
Secondary	Number of participants with death at day 60		day 60