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Acute Myocardial InfarctionFRENCHIENCT04050956

French Cohort of Myocardial Infarction Evaluation

An observational study of Acute Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
How many people
30,000 participants
Where
1 siteFrance
Study dates
11 Mar 2019to 22 Mar 2049
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive eligible (cf eligibility criteria) patients admitted in one of the Intensive Coronary Units participating to the study.

Who may be able to join

  • Myocardial infarction (MI) 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")

Who cannot join

  • Iatrogenic MI defined as MI occurring within 48h of a therapeutic procedure
  • AMI diagnosis invalidated in favor of another diagnosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tabassome SIMON contact

01 40 01 13 93

tabassome.simon@aphp.fr

Philippe Gabriel STEG contact

01 40 25 80 80 ext. +33

gabriel.steg@aphp.fr

France1 site, 1 recruiting

  • Hôpital Bichat, AP-HP

    Paris, 75018

    Philippe gabriel STEG, PU-PH, 00 33 01 40 25 89 69, gabriel.steg@aphp.fr

    Nicolas DANCHIN

    Recruiting

Other trials in France

About this study

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.

Read the 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.

Keywords
Acute Myocardial Infarction, Registry, Outcomes, Medico-economic evaluation, Comorbidities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04050956
Study groupRoleWhat they receive
Myocardial infarctionAs it is an observational study, no intervention is planned. However, nested clinical interventional trials are planned for which a specific registration will be done

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. In-hospital mortality

    In-hospital mortality

    Measured: Through the end of initial hospitalization, an average of 5 days

  2. In-hospital outcomes

    To measure the in-hospital major cardiovascular events : recurrence of AMI, myocardial revascularization, stroke

    Measured: Through the end of initial hospitalization, an average of 5 days

  3. Lipopretein 1 evolution

    To evaluate plasma concentrations of Lpa and its dynamic pattern during hospital index and 3-9 months following hospitalization.

    Measured: 9 months after the end of initial hospitalization

Secondary outcomes (9)

  1. Cardiovascular outcomes during follow-up

    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

    Measured: Up to 20 years

  2. Non cardiovascular outcomes during follow-up

    All cause death and Non-cardiovascular events leading to to hospitalizations

    Measured: Up to 20 years

  3. Relationship between patients profile and mortality and cardiovascular morbidity outcomes according to management

    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

    Measured: Up to 20 years

  4. Relationship between patients profile and mortality and non-cardiovascular morbidity outcomes according to management

    All cause death and Non-cardiovascular events leading to to hospitalizations according to patient's management

    Measured: Up to 20 years

  5. Oral comorbidities

    Prevalence of oral pathology and its relationship with early, mid, and long-term prognosis and outcomes

    Measured: Up to 20 years

  6. Sleep disordered breathing comorbidities

    To assess the prevalence of sleep disordered breathing comorbidities and the relationship with early, mid, and long-term prognosis and outcomes

    Measured: Up to 20 years

  7. Evaluate the path of care combined with patient care practices following an acute myocardial infarction

    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

    Measured: Up to 20 years

  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

    Evaluate the relevance of ESC, AHA/ACC guidelines regarding management of AMI patients

    Measured: Up to 20 years

  9. Cost-utility: incremental (or decremental) cost-utility ratio during follow-up

    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.

    Measured: Up to 20 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start11 Mar 2019
  3. Primary completion22 Mar 2029 (estimated)
  4. Study completion22 Mar 2049 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04050956
Sponsor's protocol ID
NI17011
Acronym
FRENCHIE
Status last verified
Jun 2025
First submitted
2 Aug 2019
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hasdai D, Behar S, Wallentin L, Danchin N, Gitt AK, Boersma E, Fioretti PM, Simoons ML, Battler A. A prospective survey of the characteristics, treatments and outcomes of patients with acute coronary syndromes in Europe and the Mediterranean basin; the Euro Heart Survey of Acute Coronary Syndromes (Euro Heart Survey ACS). Eur Heart J. 2002 Aug;23(15):1190-201. doi: 10.1053/euhj.2002.3193.

    PubMed 12127921

  • Pedersen TR, Kjekshus J, Berg K, Haghfelt T, Faergeman O, Faergeman G, Pyorala K, Miettinen T, Wilhelmsen L, Olsson AG, Wedel H; Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S). 1994. Atheroscler Suppl. 2004 Oct;5(3):81-7. doi: 10.1016/j.atherosclerosissup.2004.08.027. No abstract available.

    PubMed 15531279

  • Sacks FM, Pfeffer MA, Moye LA, Rouleau JL, Rutherford JD, Cole TG, Brown L, Warnica JW, Arnold JM, Wun CC, Davis BR, Braunwald E. The effect of pravastatin on coronary events after myocardial infarction in patients with average cholesterol levels. Cholesterol and Recurrent Events Trial investigators. N Engl J Med. 1996 Oct 3;335(14):1001-9. doi: 10.1056/NEJM199610033351401.

    PubMed 8801446

  • Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20,536 high-risk individuals: a randomised placebo-controlled trial. Lancet. 2002 Jul 6;360(9326):7-22. doi: 10.1016/S0140-6736(02)09327-3.

    PubMed 12114036

  • GUSTO investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. N Engl J Med. 1993 Sep 2;329(10):673-82. doi: 10.1056/NEJM199309023291001.

    PubMed 8204123

  • Andersen HR, Nielsen TT, Rasmussen K, Thuesen L, Kelbaek H, Thayssen P, Abildgaard U, Pedersen F, Madsen JK, Grande P, Villadsen AB, Krusell LR, Haghfelt T, Lomholt P, Husted SE, Vigholt E, Kjaergard HK, Mortensen LS; DANAMI-2 Investigators. A comparison of coronary angioplasty with fibrinolytic therapy in acute myocardial infarction. N Engl J Med. 2003 Aug 21;349(8):733-42. doi: 10.1056/NEJMoa025142.

    PubMed 12930925

  • Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review of 23 randomised trials. Lancet. 2003 Jan 4;361(9351):13-20. doi: 10.1016/S0140-6736(03)12113-7.

    PubMed 12517460

  • Danchin N, Vaur L, Genes N, Etienne S, Angioi M, Ferrieres J, Cambou JP. Treatment of acute myocardial infarction by primary coronary angioplasty or intravenous thrombolysis in the "real world": one-year results from a nationwide French survey. Circulation. 1999 May 25;99(20):2639-44. doi: 10.1161/01.cir.99.20.2639.

    PubMed 10338456

  • Danchin N, Vaur L, Genes N, Renault M, Ferrieres J, Etienne S, Cambou JP. Management of acute myocardial infarction in intensive care units in 1995: a nationwide French survey of practice and early hospital results. J Am Coll Cardiol. 1997 Dec;30(7):1598-605. doi: 10.1016/s0735-1097(97)00371-9.

    PubMed 9385882

  • Hanania G, Cambou JP, Gueret P, Vaur L, Blanchard D, Lablanche JM, Boutalbi Y, Humbert R, Clerson P, Genes N, Danchin N; USIC 2000 Investigators. Management and in-hospital outcome of patients with acute myocardial infarction admitted to intensive care units at the turn of the century: results from the French nationwide USIC 2000 registry. Heart. 2004 Dec;90(12):1404-10. doi: 10.1136/hrt.2003.025460.

    PubMed 15547013

  • Danchin N, Blanchard D, Steg PG, Sauval P, Hanania G, Goldstein P, Cambou JP, Gueret P, Vaur L, Boutalbi Y, Genes N, Lablanche JM; USIC 2000 Investigators. Impact of prehospital thrombolysis for acute myocardial infarction on 1-year outcome: results from the French Nationwide USIC 2000 Registry. Circulation. 2004 Oct 5;110(14):1909-15. doi: 10.1161/01.CIR.0000143144.82338.36. Epub 2004 Sep 27.

    PubMed 15451803

  • Ferrieres J, Cambou JP, Gueret P, Boutalbi Y, Lablanche JM, Hanania G, Genes N, Cantet C, Danchin N. Effect of early initiation of statins on survival in patients with acute myocardial infarction (the USIC 2000 Registry). Am J Cardiol. 2005 Feb 15;95(4):486-9. doi: 10.1016/j.amjcard.2004.10.016.

    PubMed 15695134

  • Heidenreich PA, Alloggiamento T, Melsop K, McDonald KM, Go AS, Hlatky MA. The prognostic value of troponin in patients with non-ST elevation acute coronary syndromes: a meta-analysis. J Am Coll Cardiol. 2001 Aug;38(2):478-85. doi: 10.1016/s0735-1097(01)01388-2.

    PubMed 11499741

  • Cambou JP, Simon T, Mulak G, Bataille V, Danchin N. The French registry of Acute ST elevation or non-ST-elevation Myocardial Infarction (FAST-MI): study design and baseline characteristics. Arch Mal Coeur Vaiss. 2007 Jun-Jul;100(6-7):524-34.

    PubMed 17893635

  • Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrieres J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarction 2010. FAST-MI 2010. Heart. 2012 May;98(9):699-705. doi: 10.1136/heartjnl-2012-301700.

    PubMed 22523054

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Infarction, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tabassome SIMON (01 40 01 13 93, tabassome.simon@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In-hospital mortality (time frame: Through the end of initial hospitalization, an average of 5 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04050956, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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