IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction

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Abstract

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.

Dates

Last Verified:	09/30/2018
First Submitted:	09/07/2005
Estimated Enrollment Submitted:	09/07/2005
First Posted:	09/11/2005
Last Update Submitted:	10/04/2018
Last Update Posted:	10/08/2018
Actual Study Start Date:	06/08/1999
Estimated Primary Completion Date:	10/14/2007
Estimated Study Completion Date:	10/14/2007

Condition or disease

Acute Myocardial Infarction

Intervention/treatment

Device: Implantable cardioverter defibrillator

Phase

Phase 4

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	All
Accepts Healthy Volunteers	Yes
Criteria	Inclusion Criteria: - acute myocardial infarction (5-31 days) - fulfill requirement I and/or II : - I first ECG heart rate >= 90 bpm (within day 1-2 post MI) and LVEF <= 40 % (within day 5-31 post-MI) - II >= 1 episode of non-sustained ventricular tachycardia >= 150 bpm (on Holter, within 5-31 days post-MI) Exclusion Criteria: - Patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later - Patients with therapy refractory heart failure (NYHA IV) - Myocardial infarction older than 31 days - First-ECG not available or was recorded more than 48 h after the symptom onset. - Patients with indication for CABG operation before inclusion - Patients with cerebral organic psycho syndrome - Secondary diseases which clearly limit life expectancy - Patient with right sided artificial heart valve - Patients with poor compliance - Patients who are participating in another study - Unstable clinical condition - Pregnancy - No consent from patient

Outcome

Primary Outcome Measures

1. 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. [undefined]

Secondary Outcome Measures

1. Type of death, Arrhythmic events, Serious cardiac and cerebral interventions, [undefined]

2. Device-related complications, Hospitalizations, Quality of life [undefined]

IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction

Keywords

infarction

heart arrest

heart failure

myocardial infarction

antiarrhythmic