NCT04584463

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

October 30, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

October 6, 2020

Last Update Submit

October 6, 2020

Conditions

Out-Of-Hospital Cardiac ArrestMyocardial InfarctionComaOutcome, FatalNeurologic Dysfunction

Outcome Measures

Primary Outcomes (1)

  • Neurologic outcome (CPC)

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

    30 day from in-ICU admission

Secondary Outcomes (2)

  • Neurologic outcome (Rankin)

    30 day from in-ICU admission

  • death

    30 day form in-ICU admission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestMyocardial InfarctionComaNeurologic Manifestations

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNervous System DiseasesSigns and Symptoms

Central Study Contacts

BRUNO LEVY, MD-PHD

CONTACT

03 83 15 40 84b.levy@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Bruno LEVY

Study Record Dates

First Submitted

October 6, 2020

First Posted

October 14, 2020

Study Start

October 30, 2020

Primary Completion

October 30, 2021

Study Completion

November 30, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share