French Registry of Acute Coronary Syndrome (Fast-MI)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

French Cardiology Society

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT00673036

First received: May 5, 2008

Last updated: July 25, 2012

Last verified: June 2012

History of Changes

Purpose

The Fast-MI registry was designed to evaluate the "real world" management of patients with acute myocardial infarction (MI), and to assess their in-hospital, medium and long-term outcomes

Condition	Intervention
Acute Myocardial Infarction	Other: Blood sample

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	French Registry of Acute Coronary Syndrome With or Without ST Elevation

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

All causes mortality at each follow-up period [ Time Frame: 6 months, each year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cardiovascular mortality [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
validation of guidelines across the country [ Time Frame: 6 month, each year ] [ Designated as safety issue: No ]
Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [ Time Frame: 6 month each year ] [ Designated as safety issue: No ]
Serum databank for evaluation of biomarkers in MI [ Time Frame: 6 month each year ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Whole blood, serum and DNA

Estimated Enrollment:	3750
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2017
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Adults (female and male) with a acute coronary syndrome	Other: Blood sample 60 ml of whole blood Other Name: Blood sample

Detailed Description:

Primary objectives : compare survival following the admission to a USIC according to the terms of care

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Admitted patients in a Unit of Coronary Intensive Care (USIC) for a acute coronary syndrome

Criteria

Inclusion Criteria:

admission within the 48 hours after the occurence of acute myocardial infarction (AMI)
written informed consent for the DNA and serum databank

Exclusion Criteria:

AMI occured within the 48 hours after therapeutic intervention (bypass, coronary angioplasty or other chirurgical intervention)
diagnostic of AMI not confirmed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673036

Locations

France
French Society of Cardiology
Paris, France, 75012

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

French Cardiology Society

Investigators

Principal Investigator:

Nicolas DANCHIN, MD PH

Assistance Publique - Hôpitaux de Paris

More Information

Publications:

Hasdai D, Lev EI, Behar S, Boyko V, Danchin N, Vahanian A, Battler A. Acute coronary syndromes in patients with pre-existing moderate to severe valvular disease of the heart: lessons from the Euro-Heart Survey of acute coronary syndromes. Eur Heart J. 2003 Apr;24(7):623-9.

[No authors listed] Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: the Scandinavian Simvastatin Survival Study (4S) Lancet. 1994 Nov 19;344(8934):1383-9.

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.

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. Summary for patients in: Curr Cardiol Rep. 2002 Nov;4(6):486-7.

[No authors listed] An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators. N Engl J Med. 1993 Sep 2;329(10):673-82.

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.

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. Review.

Schwartz GG, Olsson AG, Ezekowitz MD, Ganz P, Oliver MF, Waters D, Zeiher A, Chaitman BR, Leslie S, Stern T; Myocardial Ischemia Reduction with Aggressive Cholesterol Lowering (MIRACL) Study Investigators. Effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes: the MIRACL study: a randomized controlled trial. JAMA. 2001 Apr 4;285(13):1711-8. Summary for patients in: Curr Cardiol Rep. 2002 Nov;4(6):485.

Cannon CP, Braunwald E, McCabe CH, Rader DJ, Rouleau JL, Belder R, Joyal SV, Hill KA, Pfeffer MA, Skene AM; Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 Investigators. Intensive versus moderate lipid lowering with statins after acute coronary syndromes. N Engl J Med. 2004 Apr 8;350(15):1495-504. Epub 2004 Mar 8. Erratum in: N Engl J Med. 2006 Feb 16;354(7):778.

Gustafsson I, Torp-Pedersen C, Køber L, Gustafsson F, Hildebrandt P. Effect of the angiotensin-converting enzyme inhibitor trandolapril on mortality and morbidity in diabetic patients with left ventricular dysfunction after acute myocardial infarction. Trace Study Group. J Am Coll Cardiol. 1999 Jul;34(1):83-9.

Torp-Pedersen C, Køber L. Effect of ACE inhibitor trandolapril on life expectancy of patients with reduced left-ventricular function after acute myocardial infarction. TRACE Study Group. Trandolapril Cardiac Evaluation. Lancet. 1999 Jul 3;354(9172):9-12.

Pedersen OD, Bagger H, Kober L, Torp-Pedersen C. Trandolapril reduces the incidence of atrial fibrillation after acute myocardial infarction in patients with left ventricular dysfunction. Circulation. 1999 Jul 27;100(4):376-80.

Hall AS, Murray GD, Ball SG. Follow-up study of patients randomly allocated ramipril or placebo for heart failure after acute myocardial infarction: AIRE Extension (AIREX) Study. Acute Infarction Ramipril Efficacy. Lancet. 1997 May 24;349(9064):1493-7.

Koren MJ, Hunninghake DB; ALLIANCE Investigators. Clinical outcomes in managed-care patients with coronary heart disease treated aggressively in lipid-lowering disease management clinics: the alliance study. J Am Coll Cardiol. 2004 Nov 2;44(9):1772-9.

[No authors listed] Prevention of cardiovascular events and death with pravastatin in patients with coronary heart disease and a broad range of initial cholesterol levels. The Long-Term Intervention with Pravastatin in Ischaemic Disease (LIPID) Study Group. N Engl J Med. 1998 Nov 5;339(19):1349-57.

[No authors listed] A clinical trial comparing primary coronary angioplasty with tissue plasminogen activator for acute myocardial infarction. The Global Use of Strategies to Open Occluded Coronary Arteries in Acute Coronary Syndromes (GUSTO IIb) Angioplasty Substudy Investigators. N Engl J Med. 1997 Jun 5;336(23):1621-8. Erratum in: N Engl J Med 1997 Jul 24;337(4):287.

Danchin N, Vaur L, Genès N, Etienne S, Angioï M, Ferrières 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.

Danchin N, Vaur L, Genès N, Renault M, Ferrières 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.

Vaur L, Danchin N, Genès N, Dubroca I, Etienne S, Ferrières J, Cambou JP. Epidemiology of myocardial infarction in France: therapeutic and prognostic implications of heart failure during the acute phase. Am Heart J. 1999 Jan;137(1):49-58.

Hanania G, Cambou JP, Guéret P, Vaur L, Blanchard D, Lablanche JM, Boutalbi Y, Humbert R, Clerson P, Genès 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.

Danchin N, Blanchard D, Steg PG, Sauval P, Hanania G, Goldstein P, Cambou JP, Guéret P, Vaur L, Boutalbi Y, Genès 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. Epub 2004 Sep 27.

Ferrières J, Cambou JP, Guéret P, Boutalbi Y, Lablanche JM, Hanania G, Genès 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.

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.

Franklin K, Goldberg RJ, Spencer F, Klein W, Budaj A, Brieger D, Marre M, Steg PG, Gowda N, Gore JM; GRACE Investigators. Implications of diabetes in patients with acute coronary syndromes. The Global Registry of Acute Coronary Events. Arch Intern Med. 2004 Jul 12;164(13):1457-63.

Steg PG, Iung B, Feldman LJ, Cokkinos D, Deckers J, Fox KA, Keil U, Maggioni AP. Impact of availability and use of coronary interventions on the prescription of aspirin and lipid lowering treatment after acute coronary syndromes. Heart. 2002 Jul;88(1):20-4.

Amar J, Chamontin B, Ferriéres J, Danchin N, Grenier O, Cantet C, Cambou JP. Hypertension control at hospital discharge after acute coronary event: influence on cardiovascular prognosis--the PREVENIR study. Heart. 2002 Dec;88(6):587-91.

Danchin N, Grenier O, Ferrières J, Cantet C, Cambou JP. Use of secondary preventive drugs in patients with acute coronary syndromes treated medically or with coronary angioplasty: results from the nationwide French PREVENIR survey. Heart. 2002 Aug;88(2):159-62.

Zeller M, Cottin Y, Brindisi MC, Dentan G, Laurent Y, Janin-Manificat L, L'Huillier I, Beer JC, Touzery C, Makki H, Verges B, Wolf JE; The RICO survey working group. Impaired fasting glucose and cardiogenic shock in patients with acute myocardial infarction. Eur Heart J. 2004 Feb;25(4):308-12.

Chambless L, Keil U, Dobson A, Mähönen M, Kuulasmaa K, Rajakangas AM, Löwel H, Tunstall-Pedoe H. Population versus clinical view of case fatality from acute coronary heart disease: results from the WHO MONICA Project 1985-1990. Multinational MONItoring of Trends and Determinants in CArdiovascular Disease. Circulation. 1997 Dec 2;96(11):3849-59.

Marques-Vidal P, Ferrières J, Metzger MH, Cambou JP, Filipiak B, Löwel H, Keil U. Trends in coronary heart disease morbidity and mortality and acute coronary care and case fatality from 1985-1989 in southern Germany and south-western France. Eur Heart J. 1997 May;18(5):816-21.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Puymirat E, Taldir G, Aissaoui N, Lemesle G, Lorgis L, Cuisset T, Bourlard P, Maillier B, Ducrocq G, Ferrieres J, Simon T, Danchin N. Use of invasive strategy in non-ST-segment elevation myocardial infarction is a major determinant of improved long-term survival: FAST-MI (French Registry of Acute Coronary Syndrome). JACC Cardiovasc Interv. 2012 Sep;5(9):893-902. doi: 10.1016/j.jcin.2012.05.008.

Simon T, Taleb S, Danchin N, Laurans L, Rousseau B, Cattan S, Montely JM, Dubourg O, Tedgui A, Kotti S, Mallat Z. Circulating levels of interleukin-17 and cardiovascular outcomes in patients with acute myocardial infarction. Eur Heart J. 2013 Feb;34(8):570-7. doi: 10.1093/eurheartj/ehs263. Epub 2012 Sep 6.

Puymirat É, Aissaoui N, Silvain J, Bonello L, Cuisset T, Motreff P, Bataille V, Durand E, Cottin Y, Simon T, Danchin N; FAST-MI investigators. Comparison of bleeding complications and 3-year survival with low-molecular-weight heparin versus unfractionated heparin for acute myocardial infarction: the FAST-MI registry. Arch Cardiovasc Dis. 2012 Jun-Jul;105(6-7):347-54. doi: 10.1016/j.acvd.2012.04.002. Epub 2012 Jun 27.

Juillière Y, Cambou JP, Bataille V, Mulak G, Galinier M, Gibelin P, Benamer H, Bouvaist H, Méneveau N, Tabone X, Simon T, Danchin N; FAST-MI Investigators. Heart failure in acute myocardial infarction: a comparison between patients with or without heart failure criteria from the FAST-MI registry. Rev Esp Cardiol. 2012 Apr;65(4):326-33. Epub 2012 Feb 20.

Simon T, Steg PG, Gilard M, Blanchard D, Bonello L, Hanssen M, Lardoux H, Coste P, Lefèvre T, Drouet E, Mulak G, Bataille V, Ferrières J, Verstuyft C, Danchin N. Clinical events as a function of proton pump inhibitor use, clopidogrel use, and cytochrome P450 2C19 genotype in a large nationwide cohort of acute myocardial infarction: results from the French Registry of Acute ST-Elevation and Non-ST-Elevation Myocardial Infarction (FAST-MI) registry. Circulation. 2011 Feb 8;123(5):474-82. Epub 2011 Jan 24.

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. Epub 2008 Dec 22.

Responsible Party:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00673036 History of Changes
Other Study ID Numbers:	04-1244
Study First Received:	May 5, 2008
Last Updated:	July 25, 2012
Health Authority:	France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Coronary syndrome
Myocardial infarction
French registry

Additional relevant MeSH terms:

Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia

Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013

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