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NCT Number: NCT04050956

French Cohort of Myocardial Infarction Evaluation

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Bichat, AP-HP

Paris, 75018, France

Location status: Recruiting

Location contact

Nicolas DANCHIN

PRINCIPAL_INVESTIGATOR

Philippe gabriel STEG, PU-PH

CONTACT

[email protected]

00 33 01 40 25 89 69

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Myocardial infarction (MI) 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

Treatment and study plan

Primary outcomes

  1. In-hospital mortality

    Time frame: Through the end of initial hospitalization, an average of 5 days

    In-hospital mortality

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. Non cardiovascular outcomes during follow-up

    Time frame: Up to 20 years

    All cause death and Non-cardiovascular events leading to to hospitalizations

  3. 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

  4. 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

  5. Oral comorbidities

    Time frame: Up to 20 years

    Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes

  6. 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

  7. 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

  8. 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

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Gabriel STEG

CONTACT

[email protected]

01 40 25 80 80 ext. +33

Tabassome SIMON

CONTACT

[email protected]

01 40 01 13 93

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Novartis

Registry information

Acronym: FRENCHIE

Important dates

Study start
2019
Primary completion
2029
Study completion
2049
First posted
Aug 9, 2019
Registry last updated
Jun 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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