Clinical trial NCT00157768: IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Myocardial Infarction
Keywords: Acute myocardial infarction
Non-sustained ventricular tachycardia
Left ventricular dysfunction
Implantable cardioverter defibrillator
ICD
Risk-stratification
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2005-09-12
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

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.
Secondary outcomes:
measure: Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
measure: Device-related complications, Hospitalizations, Quality of life
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Medtronic Bakken Research Center B.V.
Study officials:
affiliation: Klinikum am Urban, Berlin, Germany
name: D. Andresen, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum Ludwigshafen, Germany
name: J. Senges, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinikum Grosshadern, Munich, Germany
name: G. Steinbeck, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Steinbeck G, Andresen D, Seidl K, Brachmann J, Hoffmann E, Wojciechowski D, Kornacewicz-Jach Z, Sredniawa B, Lupkovics G, Hofgartner F, Lubinski A, Rosenqvist M, Habets A, Wegscheider K, Senges J; IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009 Oct 8;361(15):1427-36. doi: 10.1056/NEJMoa0901889.