French Cohort of Myocardial Infarction Evaluation (FRENCHIE)
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|ClinicalTrials.gov Identifier: NCT04050956|
Recruitment Status : Recruiting
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
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.
|Condition or disease|
|Acute Myocardial Infarction|
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|
|Estimated Enrollment :||15000 participants|
|Official Title:||French Cohort of Myocardial Infarction Evaluation|
|Actual Study Start Date :||March 11, 2019|
|Estimated Primary Completion Date :||March 2024|
|Estimated Study Completion Date :||March 2026|
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
- In-hospital mortality [ Time Frame: Through the end of initial hospitalization, an average of 5 days ]In-hospital mortality
- 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
- 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
- Non cardiovascular outcomes during follow-up [ Time Frame: Up to 20 years ]All cause death and Non-cardiovascular events leading to to hospitalizations
- 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
- 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
- Oral comorbidities [ Time Frame: Up to 20 years ]Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes
- 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
- 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
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050956
|Contact: Tabassome SIMON||01 40 01 13 firstname.lastname@example.org|
|Contact: Philippe Gabriel STEG||01 40 25 80 80 ext +email@example.com|
|Contact: Nicolas DANCHIN 01 56 09 20 00 firstname.lastname@example.org|
|Principal Investigator: Nicolas DANCHIN|
|Principal Investigator:||Nicolas DANCHIN||Assistance Publique - Hôpitaux de Paris|