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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
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease
Acute Myocardial Infarction

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.

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Study Type : Observational
Estimated Enrollment : 15000 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Group/Cohort
Myocardial infarction
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



Primary Outcome Measures :
  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


Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Tabassome SIMON 01 40 01 13 93 tabassome.simon@aphp.fr
Contact: Philippe Gabriel STEG 01 40 25 80 80 ext +33 gabriel.steg@aphp.fr

Locations
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France
HEGP Recruiting
Paris, France
Contact: Nicolas DANCHIN    01 56 09 20 00    nicolasdanchin@yahoo.fr   
Principal Investigator: Nicolas DANCHIN         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
National Research Agency, France
Investigators
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Principal Investigator: Nicolas DANCHIN Assistance Publique - Hôpitaux de Paris
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04050956    
Other Study ID Numbers: NI17011
First Posted: August 9, 2019    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Acute Myocardial Infarction
Registry
Outcomes
Medico-economic evaluation
Comorbidities
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases