IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
June 30, 2025 updated by: Medtronic Cardiac Rhythm and Heart Failure
IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
900
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Maastricht, Netherlands
- Medtronic Bakken Research Center B.V.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
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Device-related complications, Hospitalizations, Quality of life
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 1999
Primary Completion (Actual)
October 15, 2007
Study Completion (Actual)
October 15, 2007
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimated)
September 12, 2005
Study Record Updates
Last Update Posted (Actual)
July 3, 2025
Last Update Submitted That Met QC Criteria
June 30, 2025
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medtronic_BRC_CRM_002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.