Rationale and design of the FRENch CoHort of myocardial Infarction Evaluation (FRENCHIE) study.
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Gautier Alexandre, Danchin Nicolas, Ducrocq Gregory, Rousseau Alexandra, Cottin Yves, Cayla Guillaume, Prunier Fabrice, Durand-Zaleski Isabelle, Ravaud Philippe, Angoulvant Denis, Coste Pierre, Lemesle Gilles, Bouleti Claire, Popovic Batric, Ferrari Emile, Silvain Johanne, Dubreuil Olivier, Lhermusier Thibault, Goube Pascal, Schiele François, Vanzetto Gérald, Aboyans Victor, Gallet Romain, Eltchaninoff Hélène, Thuaire Christophe, Dillinger Jean-Guillaume, Paganelli Franck, Gourmelen Julie, Steg Philippe Gabriel, Simon Tabassome, FRENCHIE investigators
Аннотация
AIMS: The main objectives are to describe baseline characteristics, contemporary management, in-hospital and long-term outcomes of patients with acute myocardial infarction hospitalized in tertiary care centres in France; secondary objectives are to investigate determinants of prognosis (including periodontal disease and sleep-disordered breathing), to identify gaps between evidence-based recommendations and management and to assess medical care costs for the index hospitalization and during the follow-up period.
METHODS: FRENCHIE (FRENch CoHort of myocardial Infarction Evaluation) is an ongoing prospective multicentre observational study (ClinicalTrials.gov Identifier: NCT04050956) enrolling more than 19,000 patients hospitalized for acute myocardial infarction with onset of symptoms within 48hours in 35 participating centres in France since March 2019. Main exclusion criteria are age<18 years, lack of health coverage and procedure-related myocardial infarction (types 4a and 5). Detailed information was collected prospectively, starting at admission, including demographic data, risk factors, medical history and treatments, initial management, with prehospital care pathways and medication doses, and outcomes until hospital discharge. The follow-up period (up to 20 years for each patient) is ensured by linking with the French national health database (Système national des données de santé), and includes information on death, hospital admissions, major clinical events, healthcare consumption (including drug reimbursement) and total healthcare costs. FRENCHIE is also used as a platform for cohort-nested studies - currently three randomized trials and two observational studies.
CONCLUSIONS: This nationwide large contemporary cohort with very long-term follow-up will improve knowledge about acute myocardial infarction management and outcomes in France, and provide a useful platform for nested studies and trials.