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Completed

NCT Number: NCT00157768

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

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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Key information

Conditions

Acute Myocardial Infarction Cardiovascular Diseases Heart Diseases Ventricular Dysfunction Ventricular Dysfunction, Left

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medtronic Bakken Research Center B.V.

Maastricht, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

Primary outcomes

  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.

Secondary outcomes

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

  2. Device-related complications, Hospitalizations, Quality of life

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
1999
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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