Overview

This trial is active, not recruiting.

Condition acute myocardial infarction
Treatment implantable cardioverter defibrillator
Phase phase 4
Sponsor Medtronic Bakken Research Center
Collaborator AstraZeneca
Start date June 1999
End date April 2008
Trial size 900 participants
Trial identifier NCT00157768, Medtronic_BRC_CRM_002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic

Primary Outcomes

Measure
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.
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)
Principal investigator D. Andresen, Prof.
Trial information was received from ClinicalTrials.gov and was last updated in August 2008.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.