Clinical trial NCT04050956: French Cohort of Myocardial Infarction Evaluation
Official title: French Cohort of Myocardial Infarction Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Myocardial Infarction
Keywords: Acute Myocardial Infarction
Registry
Outcomes
Medico-economic evaluation
Comorbidities
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: National Research Agency, France
First posted: 2019-08-09
Enrollment: 15000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: Through the end of initial hospitalization, an average of 5 days
measure: In-hospital outcomes
timeFrame: Through the end of initial hospitalization, an average of 5 days
measure: Lipopretein 1 evolution
timeFrame: 9 months after the end of initial hospitalization
Secondary outcomes:
measure: Cardiovascular outcomes during follow-up
timeFrame: Up to 20 years
measure: Non cardiovascular outcomes during follow-up
timeFrame: Up to 20 years
measure: Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management
timeFrame: Up to 20 years
measure: Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management
timeFrame: Up to 20 years
measure: Oral comorbidities
timeFrame: Up to 20 years
measure: Sleep disordered breathing comorbidities
timeFrame: Up to 20 years
measure: Evaluate the path of care combined with patient care practices following an acute myocardial infarction
timeFrame: Up to 20 years
measure: Evaluate the relevance of European Society of Cardiology (ESC), American Heart Association/American College of Cardiology (AHA / ACC) guidelines regarding management of AMI patients
timeFrame: Up to 20 years
measure: Cost-utility: incremental (or decremental) cost-utility ratio during follow-up
timeFrame: Up to 20 years
Other outcomes:
Locations:
city: Paris
country: France
facility: HEGP
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Nicolas DANCHIN
role: PRINCIPAL_INVESTIGATOR
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