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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable cardioverter defibrillator | Device |
| Measure | Description | Time Frame |
|---|---|---|
| The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different. |
| Measure | Description | Time Frame |
|---|---|---|
| Type of death, Arrhythmic events, Serious cardiac and cerebral interventions, | ||
| Device-related complications, Hospitalizations, Quality of life |
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Inclusion Criteria:
acute myocardial infarction (5-31 days)
fulfill requirement I and/or II :
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medtronic Bakken Research Center B.V. | Maastricht | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19812399 | Derived | Steinbeck G, Andresen D, Seidl K, Brachmann J, Hoffmann E, Wojciechowski D, Kornacewicz-Jach Z, Sredniawa B, Lupkovics G, Hofgartner F, Lubinski A, Rosenqvist M, Habets A, Wegscheider K, Senges J; IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009 Oct 8;361(15):1427-36. doi: 10.1056/NEJMoa0901889. |
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| ID | Term |
|---|---|
| D018487 | Ventricular Dysfunction, Left |
| ID | Term |
|---|---|
| D018754 | Ventricular Dysfunction |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |