Transcriptome Assessment After Cardiac Arrest

Not Applicable

Completed

• Conditions: Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation

• Registration Number: NCT03895736
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-27
• Study First Posted: 2019-03-29
• Study Start: 2020-02-24
• Primary Completion: 2022-02-10
• Study Completion: 2022-02-10
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Early Transcriptome at hospital admission	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
Pittsburgh Cerebral Performance Category at Day 60	Day 60	Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Cochin, Assistance Publique Hôpitaux de Paris; 🇫🇷 Paris, France