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French Cohort of Myocardial Infarction Evaluation (FRENCHIE)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Acute Myocardial Infarction

Study type

Observational

Funder types

Other

Identifiers

NCT04050956
NI17011

Details and patient eligibility

About

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.

Full 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.

Enrollment

15,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

15,000 participants in 1 patient group

Myocardial infarction
Description:
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

Trial contacts and locations

1

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Central trial contact

Tabassome SIMON; Philippe Gabriel STEG

Data sourced from clinicaltrials.gov

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