Out-Of-Hospital Cardiac ArrestACR-MINCT04584463
Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.
An observational study of Out-Of-Hospital Cardiac Arrest and Myocardial Infarction, run by Central Hospital, Nancy, France.
Trial summary
This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Coma
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2020to 30 Nov 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patient older than 18 years old admitted in an ICU following resurected out-of-hospital cardiac arrest due to a type 1 myocardial infarction
Who may be able to join
- aged of 18 years old or more
- non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation
- patient admitted in ICU
- the reason for admission is a resurected out-of-hospital cardiac arrest
- the cause of the cardiac arrest is a type 1 myocardial infarction
Who cannot join
- refractory cardiac arrest (no flow > 30 minutes in normothermia)
- in-hospital cardiac arrest
- pregnancy
- patient under juridic protection
- opposition of the patient, or of his family is he is unable to consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Factors Associated With Neurological Prognosis 30 Days After an ICU Admission for a Myocardial Infarction Complicated by an Out-of-Hospital Cardiac Arrest : an Observationnal Multicentric Study
This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.
Read the detailed description
Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome.
This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest.
This is designed to be a observationnal, prospective, multicentric national french study
- Conditions
- Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Coma, Outcome, Fatal, Neurologic Dysfunction
- Medical subject headings
- Out-of-Hospital Cardiac Arrest, Myocardial Infarction, Coma, Neurologic Manifestations
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic outcome (CPC)
Cerebral Performance Category Scale to assess neurologic outcome 1-2 : good outcome 3-4-5 : bad outcome
Measured: 30 day from in-ICU admission
Secondary outcomes (2)
Neurologic outcome (Rankin)
Rankin score to assess neurologic outcome
- 0-1-2 good outcome
- 3-4-5 bad outcome
Measured: 30 day from in-ICU admission
death
all-causes death
Measured: 30 day form in-ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start30 Oct 2020 (estimated)
- Primary completion30 Oct 2021 (estimated)
- Study completion30 Nov 2021 (estimated)
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 ArrestStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr Bruno LEVY, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584463
- Sponsor's protocol ID
- 2019PI166
- Acronym
- ACR-MI
- Status last verified
- Oct 2020
- First submitted
- 6 Oct 2020
- Last updated
- 14 Oct 2020
- 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 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Neurological Prognosis 30 Days After an ICU Admission for a Myocardial Infarction Complicated by an Out-of-Hospital Cardiac Arrest : an Observationnal Multicentric Study
- ClinicalTrials.gov ID
- NCT04584463
- Acronym / sponsor ID
- ACR-MI / 2019PI166
- Conditions
- Out-Of-Hospital Cardiac Arrest, Myocardial Infarction, Coma, Outcome, Fatal, Neurologic Dysfunction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Oct 2020 (estimated)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 14 Oct 2020 (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.
This study evaluate the association of some in-ICU factors with the neurological prognosis of patients admitted for an out-of-hospital cardiac arrest due to a myocardial infarction.
Detailed description
Pre-hospital factors associated with poor neurologic outcome are well known. Meanwhile, in-ICU factors for the first 24 hours may impact neurologic outcome.
This observational study aim to study the factors such as ECLS, NSE dosage, therapeutic hypotermia... and their association with neurologic outcome in patient with myocardial infarction due to instable coronaropathy complicated by an out-of-+hospital cardiac arrest.
This is designed to be a observationnal, prospective, multicentric national french study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient older than 18 years old admitted in an ICU following resurected out-of-hospital cardiac arrest due to a type 1 myocardial infarction
Key inclusion criteria (5 listed)
- aged of 18 years old or more
- non opposition of the patient, or his family if he is unable to consent, after loyal and comprehensive explanation
- patient admitted in ICU
- the reason for admission is a resurected out-of-hospital cardiac arrest
- the cause of the cardiac arrest is a type 1 myocardial infarction
Key exclusion criteria (5 listed)
- refractory cardiac arrest (no flow > 30 minutes in normothermia)
- in-hospital cardiac arrest
- pregnancy
- patient under juridic protection
- opposition of the patient, or of his family is he is unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neurologic outcome (CPC)
Time frame: 30 day from in-ICU admission
Cerebral Performance Category Scale to assess neurologic outcome 1-2 : good outcome 3-4-5 : bad outcome
2 secondary outcomes
Neurologic outcome (Rankin)
Time frame: 30 day from in-ICU admission
death
Time frame: 30 day form in-ICU admission
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Out-Of-Hospital Cardiac Arrest
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Out-Of-Hospital Cardiac Arrest and Myocardial Infarction, run by Central Hospital, Nancy, 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 5 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: status not confirmed, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BRUNO LEVY, MD-PHD (03 83 15 40 84 ext. +0033, b.levy@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic outcome (CPC) (time frame: 30 day from in-ICU admission). 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 14 Oct 2020; AzTrials last refreshed its copy on 6 Nov 2026.