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ACR-MI: Factors Associated With CPC 1-2 in 110 Patients Admitted in French ICU for a Myocardial Infarction Complicated by an OHCA.

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04584463
Collaborator
(none)
110
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Anticipated Study Start Date :
    Oct 30, 2020
    Anticipated Primary Completion Date :
    Oct 30, 2021
    Anticipated Study Completion Date :
    Nov 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Neurologic outcome (CPC) [30 day from in-ICU admission]

      Cerebral Performance Category Scale to assess neurologic outcome 1-2 : good outcome 3-4-5 : bad outcome

    Secondary Outcome Measures

    1. Neurologic outcome (Rankin) [30 day from in-ICU admission]

      Rankin score to assess neurologic outcome 0-1-2 good outcome 3-4-5 bad outcome

    2. death [30 day form in-ICU admission]

      all-causes death

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pr Bruno LEVY, Professor Bruno LEVY, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT04584463
    Other Study ID Numbers:
    • 2019PI166
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Oct 14, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neurologic Manifestations
    Myocardial Infarction
    Heart Arrest
    Out-of-Hospital Cardiac Arrest
    Infarction

    Study Results

    No Results Posted as of Oct 14, 2020