DAPA (Defibrillator After Primary Angioplasty) ¡V Randomized Trial.

Recruiting

Conditions: primary angioplasty for acute MI within 30-60 days with at least one of the following criteria:<br /> 1) TIMI flow after PCI less than 3
<br /> 2) left ventricular ejection (LVEF) lower than 30% as measured within 4 days after hospital admission.

Registration Number: NL-OMON28488

Lead Sponsor: A.R. Ramdat Misier, MD, PhD, Zwolle, The NetherlandsJ.P. Ottervanger MD, PhD, Zwolle, The NetherlandsProf. M.J. Schalij MD, PhD, Leiden, The NetherlandsProf. F. Zijlstra MD, PhD, Groningen, The NetherlandsE.F.D. Wever MD, PhD, Nieuwegein, The NetherlandsM.J. de Boer, MD, PhD (Zwolle, The Netherlands)W. Beukema, MD (Zwolle, The Netherlands)L. van Erven, MD, PhD (Leiden, The Netherlands)I.C. van Gelder, MD, PhD (Groningen, The Netherlands)

Brief Summary: 1. Priori SG, Aliot E, Blomstrom-Lundqvist C, et al. Task Force on Sudden Cardiac Death of the European Society of Cardiology. Eur Heart J 2001;22:1374-1450. 2. Kagan A, Yano K, Reed DM, Maclean CJ. Predictors of sudden cardiac death among Hawaiian Japanese men. Am J Epidemiol. 1989;130:268-277. 3. Boersma E, Mercado N, Polderman D, Gardien M, Vos J, Simoons ML. Acute myocardial infarction. Lancet 2003;361:847-58. 4. PCAT Collaborators. Primary coronary angioplasty compared with intravenous thrombolytic therapy for acute myocardial infarction: Six-month follow-up and analysis of individual patient data from randomized trials. Am Heart J 2003;145:47-57. 5. Keeley EC, Boura JA, Grines CL. Primary angioplasty versus intravenous thrombolytic therapy for acute myocardial infarction: a quantitive review of 23 randomised trials. Lancet 2003;361:13-20. 6. Marcus FI, Cobb LA, Edwards JE, et al. Mechanism of death and prevalence of myocardial ischemic symptoms in the terminal event after acute myocardial infarction. Am J Cardiol 1988;61:8-15. 7. Statters DJ, Malik M, Redwood S, Hnatkova K, Staunton A, Camm AJ. Use of ventricular premature complexes for risk stratification after acute myocardial infarction in the thrombolytic era. Am J Cardiol 1996;77:133-8. 8. Farb A, Tang AL, Burke AP, Sessums L, Liang Y, Virmani R. Sudden coronary death. Frequency of active coronary lesions, inactive coronary lesions, and myocardial infarction. Circulation 1995;92:1701-9. 9. Zijlstra F, Hoorntje JC, de Boer MJ, et al. Long-term benefit of primary angioplasty as compared with thrombolytic therapy for acute myocardial infarction. N Engl J Med 1999;341:1413-9. 10. Copie X, Hnatkova K, Staunton A, Fei L, Camm AJ, Malik M. Predictive power of increased heart rate versus depressed left ventricular ejection fraction and heart rate variability for risk stratification after myocardial infarction. Results of a two-year follow-up study. J Am Coll Cardiol 1996;27:270-6. 11. Hohnloser SH, Franck P, Klingenheben T, Zabel M, Just H. Open infarct artery, late potentials, and other prognostic factors in patients after acute myocardial infarction in the thrombolytic era. A prospective trial. Circulation 1994;90:1747-56. 12. van 't Hof AW, Liem A, Suryapranata H, Hoorntje JC, de Boer MJ, Zijlstra F. Angiographic assessment of myocardial reperfusion in patients treated with primary angioplasty for acute myocardial infarction: myocardial blush grade. Zwolle Myocardial Infarction Study Group. Circulation 1998;97:2302-6. 13. Poli A, Fetiveau R, Vandoni P, et al. Integrated analysis of myocardial blush and ST-segment elevation recovery after successful primary angioplasty: Real-time grading of microvascular reperfusion and prediction of early and late recovery of left ventricular function. Circulation 2002;106:313-8. 14. van 't Hof AW, Liem A, de Boer MJ, Zijlstra F. Clinical value of 12-lead electrocardiogram after successful reperfusion therapy for acute myocardial infarction. Zwolle Myocardial infarction Study Group. Lancet 1997;350:615-9. 15. The Antiarrhythymics versus Implantable Defibrillators (AVID) Investigators. A comparison of antiarrhyhmic-drug therapy with implantable defibrillators in patients resuscitated from-near fatal ventricular arrhythmias. N Engl J Med 1997;337:1576-1583. 16. Siebels J, Kuck KH. Implantable cardioverter defibrillator compared with antiarrhythmic drug treatment in cardiac arrest survivors (the Cardiac Arrest Study Hamburg). Am Heart J 1994;127(4 Pt 2):1139-44 17. Connoly SJ, Gent M, Roberts RS et al. Canadian Implantable Defibrillator Study (CIDS): a randomized trial of the implantable cardioverter defibrillator against amiodarone. Circulation 2000;101:1297-302. 18. Holmberg M, Holmberg S, Herlitz J, Gardelöf B, for the Swedish Cardiac Arrest Registry. Survival after cardiac arrest outside hospital in Sweden. Resuscitation 1998:36;29-36. 19. Moss AJ, Hall WJ, Cannon DS, et al. Improved survival with an implanted defibrillator in patients with coronary disease at high risk for ventricular arrhythmias. N Engl J Med 1996;335:1933-40. 20. Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley GE. A randomized study of the prevention of sudden death in patients with coronary artery disease. N Engl J Med 1999;341:1882-90. 21. Buxton AE, Lee KL, DiCarlo L, et al. Electrophysiologic testing to identify patients with coronary artery disease who are at risk for sudden cardiac death. N Engl J Med 2000;342:1937-45. 22. Moss AJ, Zareba W, Hall WJ, et al. Prophylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med 2002;346:877-83. 23. ACC/AHA/NASPE 2002 Guideline Update for Implantation of Cardiac Pacemakers and Antiarrhythmia Devices: Summary Article: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation 2002;106:2145-61. 24. Ezekowitz JA, Armstrong PW, McAlister FA. Implantable Cardioverter Defibrillators in Primary and Secondary Prevention: A Systematic Review of Randomized, Controlled Trials. Ann Intern Med. 2003;138:445-452. 25. Buxton AE, Lee KL, Hafley GA et al. Relation of Ejection Fraction and Inducible Ventricular Tachycardia to Mode of Death in Patients With Coronary Artery Disease. Circulation 2002;106:2466-2472. 26. Reynolds MR, Josephson ME. MADIT II (Second Multicenter Automated Defibrillator Implantation Trial ) Debate. Circulation 2003;108:1779-1783. 27. Wilber DJ, Zareba W, Hall WJ, et al. Time dependence of mortality risk and defibrilllator benefit after myocardial infarction. Circulation 2004;109:1082-1084. 28. Ottervanger JP, Van't Hof AW, Reiffers S, et al. Long-term recovery of left ventricular function after primary angioplasty for acute myocardial infarction.Eur Heart J 2001;22:785-902. 29. Scheller B, Hennen B, Hammer B, et al. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol 2003;42:634-41.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 700

Inclusion Criteria

ST-elevation myocardial infarction treated with primary PCI within 30 days and 60 days before randomisation2.At least one of the following criteria:

1. TIMI flow after primary PCI less than 3 in the infarct related vessel;

Exclusion Criteria

1. Class I indication for ICD implantation;

2. Documented previous myocardial infarction with LVEF < 30%;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is all-cause mortality.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are the incidence of sudden cardiac death and sustained ventricular tachycardia (VT). Sudden cardiac death is defined as occurring within 1 hour of the onset of symptoms or, if death is not witnessed, during sleep or within 24 hours of last occasion on which the patient was seen in a healthy state.