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

IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00157768

Enrollment

900

Registered

2005-09-12

Start date

1999-06-09

Completion date

2007-10-15

Last updated

2025-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarction, Non-sustained ventricular tachycardia, Left ventricular dysfunction, Implantable cardioverter defibrillator, ICD, Risk-stratification

Brief summary

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.

Interventions

DEVICEImplantable cardioverter defibrillator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	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.	—

Secondary

Measure	Time frame
Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,	—
Device-related complications, Hospitalizations, Quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026