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French Cohort of Myocardial Infarction Evaluation

French Cohort of Myocardial Infarction Evaluation

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04050956
Acronym
FRENCHIE
Enrollment
30000
Registered
2019-08-09
Start date
2019-03-11
Completion date
2049-03-22
Last updated
2025-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute Myocardial Infarction, Registry, Outcomes, Medico-economic evaluation, Comorbidities

Brief summary

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.

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.

Interventions

None listed

Sponsors

Novartis
CollaboratorINDUSTRY
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Lipopretein 1 evolution9 months after the end of initial hospitalizationTo evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.
In-hospital mortalityThrough the end of initial hospitalization, an average of 5 daysIn-hospital mortality
In-hospital outcomesThrough the end of initial hospitalization, an average of 5 daysTo measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke

Secondary

MeasureTime frameDescription
Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to managementUp to 20 yearsAll cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management
Oral comorbiditiesUp to 20 yearsPrevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes
Sleep disordered breathing comorbiditiesUp to 20 yearsTo assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes
Cardiovascular outcomes during follow-upUp to 20 yearsAll cause death and Cardiovascular events including non fatal Myocardial Infarction, non fatal stroke, revascularization, hospitalization for other cardiovascular causes including Bleeding leading to hospitalization
Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patientsUp to 20 yearsEvaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients
Cost-utility: incremental (or decremental) cost-utility ratio during follow-upUp to 20 yearsMedical 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.
Evaluate the path of care combined with patient care practices following an acute myocardial infarctionUp to 20 yearsEvaluate 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
Non cardiovascular outcomes during follow-upUp to 20 yearsAll cause death and Non-cardiovascular events leading to to hospitalizations
Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to managementUp to 20 yearsAll 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

Countries

France

Contacts

Primary ContactTabassome SIMON
tabassome.simon@aphp.fr01 40 01 13 93
Backup ContactPhilippe Gabriel STEG
gabriel.steg@aphp.fr01 40 25 80 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026