IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction - Full Text View

Sponsors and Collaborators:	Medtronic Bakken Research Center AstraZeneca
Information provided by:	Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:	NCT00157768

Purpose

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.

Condition	Intervention	Phase
Acute Myocardial Infarction	Device: Implantable cardioverter defibrillator	Phase IV

MedlinePlus related topics: Heart Attack Pacemakers and Implantable Defibrillators

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:

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 Measures:

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

Estimated Enrollment:	900
Study Start Date:	June 1999
Estimated Study Completion Date:	April 2008

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157768

Locations

Netherlands
Medtronic Bakken Research Center B.V.
Maastricht, Netherlands

Sponsors and Collaborators

Medtronic Bakken Research Center

AstraZeneca

Investigators

Principal Investigator:	D. Andresen, Prof.	Klinikum am Urban, Berlin, Germany
Principal Investigator:	J. Senges, Prof.	Herzzentrum Ludwigshafen, Germany
Principal Investigator:	G. Steinbeck, Prof.	Klinikum Grosshadern, Munich, Germany

More Information

No publications provided

Study ID Numbers:	Medtronic_BRC_CRM_002
Study First Received:	September 8, 2005
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00157768 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medtronic Bakken Research Center:

Acute myocardial infarction
Non-sustained ventricular tachycardia
Left ventricular dysfunction

Implantable cardioverter defibrillator
ICD
Risk-stratification

Study placed in the following topic categories:

Ventricular Dysfunction
Necrosis
Heart Diseases
Myocardial Ischemia
Tachycardia
Vascular Diseases

Ventricular Dysfunction, Left
Ischemia
Infarction
Tachycardia, Ventricular
Myocardial Infarction

Additional relevant MeSH terms:

Necrosis
Heart Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases

Cardiovascular Diseases
Ischemia
Infarction
Myocardial Infarction

ClinicalTrials.gov processed this record on May 06, 2009