IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarc… (NCT00157768) | Clinical Trial Compass
CompletedPhase 4
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Netherlands900 participantsStarted 1999-06-09
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.