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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01237418
Other study ID # 10240
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 2010
Est. completion date December 2022

Study information

Verified date September 2022
Source French Cardiology Society
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The observatory FAST MI 2010 proposes to establish a cohort of 3500 patients recruited prospectively over a period of 2 months. Patients will be followed up at 1 month and then followed annually for 10 years. Patients should have agreed to participate in the study, participation in the protocol, or refusal to participate will not affect the therapeutic approach of the physician. The study of genotypic or phenotypic characteristics will not change the therapeutic approach of health care teams.


Description:

This is a multicenter observational study, given to 300 prospective medical facilities, CHU, CHG, CHR, health facility of the Army, including a clinic or intensive care unit entitled to receive emergency ACS. (See attached list 10-6) A questionnaire will be sent to each center before the recruitment center on the type and number of beds (Appendix 10-5) Patients will be recruited consecutively in the CIAU member during a period of 2 months. The 1-month follow-up will be done by the referring physician of each ISB, by mail or telephone contact with the treating physician and / or patient. Annual follow-ups will be conducted during 10 years of clinical research technicians of the French Society of Cardiology, mail and / or telephone contact with the municipalities of birth, treating physicians and patients.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 3700
Est. completion date December 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria : - Patients over 18 years old - Admitted patient for a myocardial infarction (MI) of less than 48 hours, characterized by the typical rise and fall of troponin or CPKMb associated with at least one of the following: symptoms of myocardial ischemia or appearance of pathological Q waves or repolarization disorders related to ischemia (in addition to or NSTEMI) - Patient who consented to participate in the study Exclusion Criteria: - Refusal of consent - MI occurring within 48 h after a therapeutic intervention (angioplasty or coronary bypass or other surgery) - Diagnosis of SCA reversed in favor of an alternative diagnosis

Study Design


Locations

Country Name City State
France European Hospital Georges Pompidou Paris

Sponsors (1)

Lead Sponsor Collaborator
French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (33)

Aissaoui N, Puymirat E, Juilliere Y, Jourdain P, Blanchard D, Schiele F, Guéret P, Popovic B, Ferrieres J, Simon T, Danchin N. Fifteen-year trends in the management of cardiogenic shock and associated 1-year mortality in elderly patients with acute myocar — View Citation

Aissaoui N, Riant E, Lefèvre G, Delmas C, Bonello L, Henry P, Bonnefoy E, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Long-term clinical outcomes in patients with cardiogenic shock according to left ventricular function: — View Citation

Bailleul C, Aissaoui N, Cayla G, Dillinger JG, Jouve B, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Prognostic impact of prepercutaneous coronary intervention TIMI flow in patients with ST-segment and non-ST-segment elev — View Citation

Bailleul C, Puymirat E, Aissaoui N, Schiele F, Ducrocq G, Coste P, Blanchard D, Brasselet C, Elbaz M, Steg PG, Le Breton H, Bonnefoy-Cudraz E, Montalescot G, Cottin Y, Goldstein P, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Factors Associated — View Citation

Danchin N, Coste P, Ferrières J, Steg PG, Cottin Y, Blanchard D, Belle L, Ritz B, Kirkorian G, Angioi M, Sans P, Charbonnier B, Eltchaninoff H, Guéret P, Khalife K, Asseman P, Puel J, Goldstein P, Cambou JP, Simon T; FAST-MI Investigators. Comparison of thrombolysis followed by broad use of percutaneous coronary intervention with primary percutaneous coronary intervention for ST-segment-elevation acute myocardial infarction: data from the french registry on acute ST-elevation myocardial infarction (FAST-MI). Circulation. 2008 Jul 15;118(3):268-76. doi: 10.1161/CIRCULATIONAHA.107.762765. Epub 2008 Jun 30. — View Citation

Danchin N, Fauchier L, Marijon E, Barnay C, Furber A, Mabo P, Bernard P, Blanc JJ, Jouven X, Le Heuzey JY, Charbonnier B, Ferrières J, Simon T; French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Investigators. Impact of early statin therapy on development of atrial fibrillation at the acute stage of myocardial infarction: data from the FAST-MI register. Heart. 2010 Nov;96(22):1809-14. doi: 10.1136/hrt.2010.201574. — View Citation

Ferrières J, Bataille V, Puymirat E, Schiele F, Simon T, Danchin N; FAST-MI investigators. Applicability of the REDUCE-IT trial to the FAST-MI registry. Are the results of randomized trials relevant in routine clinical practice? Clin Cardiol. 2020 Nov;43( — View Citation

Hanssen M, Cottin Y, Khalife K, Hammer L, Goldstein P, Puymirat E, Mulak G, Drouet E, Pace B, Schultz E, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI 2010 Investigators. French Registry on Acute ST-elevation and non ST-elevation Myocardial Infarct — View Citation

Isorni MA, Aissaoui N, Angoulvant D, Bonello L, Lemesle G, Delmas C, Henry P, Schiele F, Ferrières J, Simon T, Danchin N, Puymirat É; FAST-MI investigators. Temporal trends in clinical characteristics and management according to sex in patients with cardi — View Citation

Massoullié G, Wintzer-Wehekind J, Chenaf C, Mulliez A, Pereira B, Authier N, Eschalier A, Clerfond G, Souteyrand G, Tabassome S, Danchin N, Citron B, Lusson JR, Puymirat É, Motreff P, Eschalier R. Prognosis and management of myocardial infarction: Compari — View Citation

Puymirat E, Aissaoui N, Bonello L, Cayla G, Labèque JN, Nallet O, Motreff P, Varenne O, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Clinical outcomes according to symptom presentation in patients with acute myocardial infarction: Re — View Citation

Puymirat E, Aissaoui N, Cayla G, Lafont A, Riant E, Mennuni M, Saint-Jean O, Blanchard D, Jourdain P, Elbaz M, Henry P, Bataille V, Drouet E, Mulak G, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Changes in One-Year Mortality in Elde — View Citation

Puymirat E, Aissaoui N, Cottin Y, Vanzetto G, Carrié D, Isaaz K, Valy Y, Tchetche D, Schiele F, Steg PG, Simon T, Danchin N. Effect of coronary thrombus aspiration during primary percutaneous coronary intervention on one-year survival (from the FAST-MI 20 — View Citation

Puymirat E, Aissaoui N, Lemesle G, Cottin Y, Coste P, Schiele F, Ferrières J, Simon T, Danchin N; FAST-MI Investigators. Long-Term Clinical Outcomes According to Previous Manifestations of Atherosclerotic Disease (from the FAST-MI 2010 Registry). Am J Car — View Citation

Puymirat E, Aissaoui N, Simon T, Bataille V, Drouet E, Mulak G, Ferrières J, Danchin N. [Acute myocardial infarction in the elderly. The FAST-MI registry]. Presse Med. 2013 Nov;42(11):1432-41. doi: 10.1016/j.lpm.2013.04.010. Epub 2013 Jul 22. Review. Fren — View Citation

Puymirat E, Bonaca M, Fumery M, Tea V, Aissaoui N, Lemesles G, Bonello L, Ducrocq G, Cayla G, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Atherothrombotic risk stratification after acute myocardial infarction: The Thrombolysis in My — View Citation

Puymirat E, Bonaca M, Iliou MC, Tea V, Ducrocq G, Douard H, Labrunee M, Plastaras P, Chevallereau P, Taldir G, Bataille V, Ferrières J, Schiele F, Simon T, Danchin N; FAST-MI investigators. Outcome associated with prescription of cardiac rehabilitation ac — View Citation

Puymirat E, Caudron J, Steg PG, Lemesle G, Cottin Y, Coste P, Schiele F, de Labriolle A, Bataille V, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Prognostic impact of non-compliance with guidelines-recommended times to reperfusion therapy in ST — View Citation

Puymirat E, Cayla G, Cottin Y, Elbaz M, Henry P, Gerbaud E, Lemesle G, Popovic B, Labèque JN, Roubille F, Andrieu S, Farah B, Schiele F, Ferrières J, Simon T, Danchin N. Twenty-year trends in profile, management and outcomes of patients with ST-segment el — View Citation

Puymirat E, Lamhaut L, Bonnet N, Aissaoui N, Henry P, Cayla G, Cattan S, Steg G, Mock L, Ducrocq G, Goldstein P, Schiele F, Bonnefoy-Cudraz E, Simon T, Danchin N. Correlates of pre-hospital morphine use in ST-elevation myocardial infarction patients and i — View Citation

Puymirat E, Schiele F, Ennezat PV, Coste P, Collet JP, Bonnefoy-Cudraz E, Roul G, Richard P, Simon T, Danchin N. Impact of fondaparinux versus enoxaparin on in-hospital bleeding and 1-year death in non-ST-segment elevation myocardial infarction. FAST-MI ( — View Citation

Puymirat E, Schiele F, Steg PG, Blanchard D, Isorni MA, Silvain J, Goldstein P, Guéret P, Mulak G, Berard L, Bataille V, Cattan S, Ferrières J, Simon T, Danchin N; FAST-MI investigators. Determinants of improved one-year survival in non-ST-segment elevati — View Citation

Puymirat E, Simon T, Cayla G, Cottin Y, Elbaz M, Coste P, Lemesle G, Motreff P, Popovic B, Khalife K, Labèque JN, Perret T, Le Ray C, Orion L, Jouve B, Blanchard D, Peycher P, Silvain J, Steg PG, Goldstein P, Guéret P, Belle L, Aissaoui N, Ferrières J, Sc — View Citation

Puymirat E, Simon T, Danchin N; FAST-MI Investigators. Response by Puymirat et al to Letter Regarding Article, "Acute Myocardial Infarction Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Progr — View Citation

Puymirat E, Teixeira N, Simon T, Steg PG, Schiele F, Lamblin N, Probst V, Juillière Y, Ferrières J, Danchin N; FAST-MI investigators. Patient education after acute myocardial infarction: cardiologists should adapt their message--French registry of acute S — View Citation

Schiele F, Gale CP, Simon T, Fox KAA, Bueno H, Lettino M, Tubaro M, Puymirat E, Ferrières J, Meneveau N, Danchin N. Assessment of Quality Indicators for Acute Myocardial Infarction in the FAST-MI (French Registry of Acute ST-Elevation or Non-ST-Elevation — View Citation

Schiele F, Puymirat E, Bonello L, Meneveau N, Collet JP, Motreff P, Ravan R, Leclercq F, Ennezat PV, Ferrières J, Simon T, Danchin N. Switching between thienopyridines in patients with acute myocardial infarction and quality of care. Open Heart. 2016 May — View Citation

Schiele F, Puymirat E, Ferrières J, Simon T, Fox KAA, Eikelboom J, Danchin N; FAST-MI investigators. The FAST-MI 2005-2010-2015 registries in the light of the COMPASS trial: The COMPASS criteria applied to a post-MI population. Int J Cardiol. 2019 Mar 1;2 — View Citation

Simon T, Puymirat E, Lucke V, Bouabdallaoui N, Lognoné T, Aissaoui N, Cohen S, Ashrafpoor G, Roul G, Jouve B, Levy G, Charpentier S, Grollier G, Ferrières J, Danchin N; au nom des investigateurs FAST-MI 2010. [Acute myocardial infarction in women. Initial — View Citation

Simon T, Verstuyft C, Mary-Krause M, Quteineh L, Drouet E, Méneveau N, Steg PG, Ferrières J, Danchin N, Becquemont L; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) Investigators. Genetic determinants of response to clopidogrel and cardiovascular events. N Engl J Med. 2009 Jan 22;360(4):363-75. doi: 10.1056/NEJMoa0808227. Epub 2008 Dec 22. — View Citation

Sokoloff A, Lefèvre G, Teixeira N, Puymirat E, Beygui F, Vanzetto G, Richard P, Khalife K, Blanchard D, Gilard M, Coste P, Farah B, Elbaz M, Leclercq F, Ferrari E, Bonnet JL, Meyer P, Belle L, Funck F, Motreff P, Virot P, Geugniaud PY, Ferrières J, Simon — View Citation

Tea V, Bonaca M, Chamandi C, Iliou MC, Lhermusier T, Aissaoui N, Cayla G, Angoulvant D, Ferrières J, Schiele F, Simon T, Danchin N, Puymirat E; FAST-MI investigators. Appropriate secondary prevention and clinical outcomes after acute myocardial infarction — View Citation

Zeller M, Danchin N, Simon D, Vahanian A, Lorgis L, Cottin Y, Berland J, Gueret P, Wyart P, Deturck R, Tabone X, Machecourt J, Leclercq F, Drouet E, Mulak G, Bataille V, Cambou JP, Ferrieres J, Simon T; French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction investigators. Impact of type of preadmission sulfonylureas on mortality and cardiovascular outcomes in diabetic patients with acute myocardial infarction. J Clin Endocrinol Metab. 2010 Nov;95(11):4993-5002. doi: 10.1210/jc.2010-0449. Epub 2010 Aug 11. — View Citation

* Note: There are 33 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Survival Compare survival in the hospital after admission in Intensive Care Unit in the manner of care 1 month
Secondary Survival in long-term 10 years
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