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

NCT00157768 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 900

Last updated 2025-07-03

No results posted yet for this study

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.

Conditions

  • Acute Myocardial Infarction

Interventions

DEVICE

Implantable cardioverter defibrillator

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • D. Andresen, Prof. · Klinikum am Urban, Berlin, Germany

  • J. Senges, Prof. · Herzzentrum Ludwigshafen, Germany

  • G. Steinbeck, Prof. · Klinikum Grosshadern, Munich, Germany

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-06-09
Primary Completion
2007-10-15
Completion
2007-10-15

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00157768 on ClinicalTrials.gov