French Registry of Acute Coronary Syndrome

Acute Myocardial Infarction Clinical Trial

— Fast-MI  

Official title:

French Registry of Acute Coronary Syndrome With or Without ST Elevation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00673036
• Other study ID #: 04-1244
• Status: Active, not recruiting
• Phase: N/A
• First received: May 5, 2008
• Last updated: January 24, 2017
• Start date: October 2005
• Est. completion date: June 2019

Study information

• Verified date: October 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3750
• Est. completion date: June 2019
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Other:
• Blood sample
60 ml of whole blood

Locations

Country	Name	City	State
France	French Society of Cardiology	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	French Cardiology Society

Country where clinical trial is conducted

France, 

References & Publications (30)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2006 Feb 16;354(7):778. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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; 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. — View Citation

* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All causes mortality at each follow-up period		6 months, each year
Secondary	Cardiovascular mortality		6 month, each year
Secondary	validation of guidelines across the country		6 month, each year
Secondary	Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes		6 month each year
Secondary	Serum databank for evaluation of biomarkers in MI		6 month each year