Out-Of-Hospital Cardiac Arrest After Initial Successful ResuscitationOMECARDNCT03895736
Transcriptome Assessment After Cardiac Arrest
A study testing blood sampling in people with Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
- What is being tested?
- blood sampling
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2020to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiac arrest supposed to be provoked by trauma or sepsis
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Cochin, Assistance Publique Hôpitaux de Paris
Paris, 75005
About this study
Official title: " 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.
Read the 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.
- Being tested
- blood sampling
- Keywords
- Transcriptome, messenger ribonucleic acid (mRNA), sequencing, biomarker, cardiac arrest, prognostication, successful resuscitation
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingBiological
Also called Blood sampling at Day 0, Day 1 and Day 3
Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Pittsburgh Cerebral Performance Category at Day 60
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 60
Measured: Day 60
Secondary outcomes (5)
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
Measured: 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
Measured: Day 3
Pittsburgh Cerebral Performance Category at Day 28
Pittsburgh Cerebral Performance Category will be evaluated for each patient at day 28
Measured: day 28
Number of participants with death at day 28
Measured: day 28
Number of participants with death at day 60
Measured: day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2019
- Study start24 Feb 2020
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out-Of-Hospital Cardiac Arrest After Initial Successful ResuscitationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University, Ecole Nationale Vétérinaire d'Alfort, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Alain Cariou, Prof., Principal investigator, Assistance Publique - Hôpitaux de ParisRenaud Tissier, Prof, Study chair, Ecole Nationale Vétérinaire d'Alfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03895736
- Sponsor's protocol ID
- 2019-A00239-48
- Other IDs
- 2019-A00239-48
- Acronym
- OMECARD
- Status last verified
- Oct 2025
- First submitted
- 21 Mar 2019
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Etude du Transcriptome Complet Lors du Syndrome Post-arrêt Cardiaque " Transcriptome Assessment After Cardiac Arrest
- ClinicalTrials.gov ID
- NCT03895736
- Acronym / sponsor ID
- OMECARD / 2019-A00239-48
- Keywords
- Transcriptome, messenger ribonucleic acid (mRNA), sequencing, biomarker, cardiac arrest, prognostication, successful resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France, University of Paris 5 - Rene Descartes, Institut National de la Santé Et de la Recherche Médicale, France, Paris 12 Val de Marne University, Ecole Nationale Vétérinaire d'Alfort, URC-CIC Paris Descartes Necker Cochin
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 29 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Cardiac arrest supposed to be provoked by trauma or sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samplingAlso: Blood sampling at Day 0, Day 1 and Day 3Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3 | Biological | – |
Primary outcome
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
5 secondary outcomes
Transcriptome at day 1
Time frame: Day 1
Transcriptome at day 3
Time frame: Day 3
Pittsburgh Cerebral Performance Category at Day 28
Time frame: day 28
Number of participants with death at day 28
Time frame: day 28
Number of participants with death at day 60
Time frame: day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation
Enrolling by invitationObservational study
A Study on the Impact of a New Canton-Wide First Responder System in Zug, Switzerland, on Survival After Adult Cardiac Arrest-Examining Early Life-Saving Organized Help, Fast Defibrillation, and Improved Outcomes for Out of Hospital Cardiac Arrest
Cardiac Arrest (CA), Cardiac Arrest With Successful Resuscitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alain Cariou, Prof. principal investigator
Assistance Publique - Hôpitaux de Paris
Renaud Tissier, Prof study chair
Ecole Nationale Vétérinaire d'Alfort
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling in people with Out-Of-Hospital Cardiac Arrest After Initial Successful Resuscitation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early Transcriptome at hospital admission (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.