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Sponsors and Collaborators: |
Medtronic Bakken Research Center AstraZeneca |
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Information provided by: | Medtronic Bakken Research Center |
ClinicalTrials.gov Identifier: | NCT00157768 |
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.
Condition | Intervention | Phase |
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Acute Myocardial Infarction |
Device: Implantable cardioverter defibrillator |
Phase IV |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK) |
Estimated Enrollment: | 900 |
Study Start Date: | June 1999 |
Estimated Study Completion Date: | April 2008 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
fulfill requirement I and/or II :
Exclusion Criteria:
Netherlands | |
Medtronic Bakken Research Center B.V. | |
Maastricht, Netherlands |
Principal Investigator: | D. Andresen, Prof. | Klinikum am Urban, Berlin, Germany |
Principal Investigator: | J. Senges, Prof. | Herzzentrum Ludwigshafen, Germany |
Principal Investigator: | G. Steinbeck, Prof. | Klinikum Grosshadern, Munich, Germany |
Study ID Numbers: | Medtronic_BRC_CRM_002 |
Study First Received: | September 8, 2005 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00157768 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Acute myocardial infarction Non-sustained ventricular tachycardia Left ventricular dysfunction |
Implantable cardioverter defibrillator ICD Risk-stratification |
Ventricular Dysfunction Necrosis Heart Diseases Myocardial Ischemia Tachycardia Vascular Diseases |
Ventricular Dysfunction, Left Ischemia Infarction Tachycardia, Ventricular Myocardial Infarction |
Pathologic Processes Cardiovascular Diseases |