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Clinical Trials/NCT03895736
NCT03895736CompletedNot Applicable

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

Assistance Publique - Hôpitaux de Paris1 site in 1 country60 target enrollmentStarted: February 24, 2020Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Early Transcriptome at hospital admission

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Early Transcriptome at hospital admission

Time Frame: 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

Time Frame: Day 60

Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60

Secondary Outcomes

  • Number of participants with death at day 60(day 60)
  • Transcriptome at day 3(Day 3)
  • Pittsburgh Cerebral Performance Category at Day 28(day 28)
  • Transcriptome at day 1(Day 1)
  • Number of participants with death at day 28(day 28)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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