IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction
Information source: Medtronic Bakken Research Center
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Myocardial Infarction
Intervention: Implantable cardioverter defibrillator (Device)
Phase: Phase 4
Status: Recruiting
Sponsored by: Medtronic Bakken Research Center Official(s) and/or principal investigator(s):
D. Andresen, Prof., Principal Investigator, Affiliation: Klinikum am Urban, Berlin, Germany
J. Senges, Prof., Principal Investigator, Affiliation: Herzzentrum Ludwigshafen, Germany
G. Steinbeck, Prof., Principal Investigator, Affiliation: Klinikum Grosshadern, Munich, Germany
Overall contact:
Fons Habets, Ph.D., Phone: +31 433566629, Email: fons.habets@medtronic.com
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.
Clinical Details
Official title: IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)
Study design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: 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 outcome: Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,Device-related complications, Hospitalizations, Quality of life
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Fons Habets, Ph.D., Phone: +31 433566629, Email: fons.habets@medtronic.com
Medtronic Bakken Research Center B.V., Maastricht, Netherlands; Recruiting
Fons Habets, Ph.D., Phone: +31 433566629, Email: fons.habets@medtronic.com
Additional Information
Starting date: June 1999
Ending date: April 2008
Last updated: June 5, 2006
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