Status:
COMPLETED
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
AstraZeneca
Conditions:
Acute Myocardial Infarction
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
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 an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 1999
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 15 2007
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT00157768
Start Date
June 9 1999
End Date
October 15 2007
Last Update
July 3 2025
Active Locations (1)
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1
Medtronic Bakken Research Center B.V.
Maastricht, Netherlands