French Cohort of Myocardial Infarction Evaluation (FRENCHIE)

April 4, 2022 updated by: Assistance Publique - Hôpitaux de Paris

Over the last two decades, considerable progress has been made in the management of Acute Myocardial Infarction (AMI), both in the acute phase and in monitoring beyond the hospital phase. Nevertheless, the evolution of care practices and their impact on the mid- and long-term prognosis of patients admitted to the intensive care unit for acute myocardial infarction remain relatively little studied exhaustively.

The aim of this study is to assess the profile of AMI patients, their management and follow-up in order to evaluate the relationship between these factors and outcomes.

Study Overview

Status

Recruiting

Conditions

Detailed Description

The FRENCHIE registry is a French multicenter prospective observational study. All the eligible consecutive patients admitted within 48 hours after symptom onset in a cardiac ICU for an acute myocardial infarction.

This hospital registry will be linked to the national databases, in order to collect follow-up clinical outcomes and health care consumption.

Study Type

Observational

Enrollment (Anticipated)

15000

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

Study Contact Backup

Study Locations

  • France
      • Paris, France
        • Recruiting
        • HEGP
        • Contact:
        • Principal Investigator:
          • Nicolas DANCHIN

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

Consecutive eligible (cf eligibility criteria) patients admitted in one of the Intensive Coronary Units participating to the study.

Description

Inclusion Criteria:

  • Myocardial infarction (IDM) within 48h of symptom onset, characterized by the typical increased or fall of troponin (or CPKMB) associated with at least one of the following elements :
  • Symptoms compatible with myocardial ischemia
  • Appearance of pathological Q waves
  • ST- T changes compatible with myocardial ischemia (ST segment elevation or depression, T-wave inversion)
  • Written consent.
  • Covered by French medical insurance ("Sécurité Sociale")

Exclusion Criteria:

  • Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure
  • AMI diagnosis invalidated in favor of another diagnosis

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

Cohorts and Interventions

Group / Cohort
Myocardial infarction
As it is an observational study, no intervention is planned. However, nested clinical interventional trials are planned for which a specific registration will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
In-hospital mortality
Time Frame: Through the end of initial hospitalization, an average of 5 days
In-hospital mortality
Through the end of initial hospitalization, an average of 5 days
In-hospital outcomes
Time Frame: Through the end of initial hospitalization, an average of 5 days
To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke
Through the end of initial hospitalization, an average of 5 days
Lipopretein 1 evolution
Time Frame: 9 months after the end of initial hospitalization
To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.
9 months after the end of initial hospitalization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular outcomes during follow-up
Time Frame: Up to 20 years
All cause death and Cardiovascular events including non fatal Myocardial Infarction, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization
Up to 20 years
Non cardiovascular outcomes during follow-up
Time Frame: Up to 20 years
All cause death and Non-cardiovascular events leading to to hospitalizations
Up to 20 years
Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management
Time Frame: Up to 20 years
All cause death and cardiovascular events including non fatal MI, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization according to patient's management
Up to 20 years
Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management
Time Frame: Up to 20 years
All cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management
Up to 20 years
Oral comorbidities
Time Frame: Up to 20 years
Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes
Up to 20 years
Sleep disordered breathing comorbidities
Time Frame: Up to 20 years
To assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes
Up to 20 years
Evaluate the path of care combined with patient care practices following an acute myocardial infarction
Time Frame: Up to 20 years
Evaluate the path of care and patient care practices following an acute myocardial infarction : Reimbursed or prescribed treatments, combined with number of visits, biological and tests performed
Up to 20 years
Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients
Time Frame: Up to 20 years
Evaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients
Up to 20 years
Cost-utility: incremental (or decremental) cost-utility ratio during follow-up
Time Frame: Up to 20 years
Medical care costs for the index hospitalization and during follow-up period are assessed using a combination of resource-based and event-based methods. In-hospital resource utilization are based on diagnosis and procedural codes and length of stay.
Up to 20 years

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

National Research Agency, France

Investigators

  • Principal Investigator: Nicolas Danchin, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 11, 2019

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

March 1, 2026

Study Registration Dates

First Submitted

August 2, 2019

First Submitted That Met QC Criteria

August 6, 2019

First Posted (Actual)

August 9, 2019

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 4, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NI17011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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