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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00157768
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Medtronic Bakken Research Center

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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Device: Implantable cardioverter defibrillator Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Actual Study Start Date : June 9, 1999
Actual Primary Completion Date : October 15, 2007
Actual Study Completion Date : October 15, 2007

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Primary Outcome Measures :
  1. 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 :
  1. Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
  2. Device-related complications, Hospitalizations, Quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00157768


Locations
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Netherlands
Medtronic Bakken Research Center B.V.
Maastricht, Netherlands
Sponsors and Collaborators
Medtronic Bakken Research Center
AstraZeneca
Investigators
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00157768    
Other Study ID Numbers: Medtronic_BRC_CRM_002
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
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:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases