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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Medtronic Bakken Research Center.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT00157768
First received: September 8, 2005
Last updated: August 4, 2008
Last verified: August 2008
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: IRIS - Immediate Risk-Stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)

Resource links provided by NLM:

U.S. FDA Resources

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 by Medtronic Bakken Research Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00157768     History of Changes
Other Study ID Numbers: Medtronic_BRC_CRM_002
Study First Received: September 8, 2005
Last Updated: August 4, 2008
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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013