Acute Myocardial InfarctionPhase 4NCT00157768
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
A Phase 4 study testing Implantable cardioverter defibrillator in people with Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Implantable cardioverter defibrillator
- Type of treatment
- Medical device
- How many people
- 900 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Jun 1999to 15 Oct 2007
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this 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)
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Implantable cardioverter defibrillator
- Keywords
- Acute myocardial infarction, Non-sustained ventricular tachycardia, Left ventricular dysfunction, Implantable cardioverter defibrillator, ICD, Risk-stratification
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable cardioverter defibrillatorDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (2)
Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Device-related complications, Hospitalizations, Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start9 Jun 1999
- Primary completion15 Oct 2007
- Study completion15 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Investigators
- D. Andresen, Prof., Principal investigator, Klinikum am Urban, Berlin, GermanyJ. Senges, Prof., Principal investigator, Herzzentrum Ludwigshafen, GermanyG. Steinbeck, Prof., Principal investigator, Klinikum Grosshadern, Munich, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00157768
- Sponsor's protocol ID
- Medtronic_BRC_CRM_002
- Status last verified
- Oct 2018
- First submitted
- 8 Sep 2005
- Last updated
- 3 Jul 2025
- Results posted
- No
Publications
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.
PubMed 19812399