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

Medtronic

Status and phase

Completed

Phase 4

Conditions

Acute Myocardial Infarction

Treatments

Device: Implantable cardioverter defibrillator

Study type

Interventional

Funder types

Industry

Identifiers

NCT00157768

Medtronic_BRC_CRM_002

Details and patient eligibility

About

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.

Enrollment

900 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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