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

October 6, 2020 updated by: Pr Bruno LEVY, Central Hospital, Nancy, France

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 day from in-ICU admission

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurologic outcome (Rankin)
Time Frame: 30 day from in-ICU admission

Rankin score to assess neurologic outcome

  • 0-1-2 good outcome
  • 3-4-5 bad outcome
30 day from in-ICU admission
death
Time Frame: 30 day form in-ICU admission
all-causes death
30 day form in-ICU admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 30, 2020

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

November 30, 2021

Study Registration Dates

First Submitted

October 6, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 14, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019PI166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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