NCT00157768

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

Completed Phase 4 Last updated 3 July 2025

What this trial tests

Phase 4 trial testing Implantable cardioverter defibrillator in Acute Myocardial Infarction in 900 participants. Completed in 15 October 2007.

Timeline

9 June 1999

Primary endpoint
15 October 2007

15 October 2007

Quick facts

Lead sponsor	Medtronic Cardiac Rhythm and Heart Failure
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	900
Start date	9 June 1999
Primary completion	15 October 2007
Estimated completion	15 October 2007
Sites	1 location across Netherlands

Drugs / interventions tested

• Implantable cardioverter defibrillator

Conditions studied

• Acute Myocardial Infarction — all drugs for Acute Myocardial Infarction →

Sponsor

Medtronic Cardiac Rhythm and Heart Failure — full company profile →

Who can join

Adults 18 to 80, any sex, with Acute Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Defibrillator implantation early after myocardial infarction.
   Steinbeck G, Andresen D, Seidl K, Brachmann J, et al · · 2009 · cited 448× · PMID 19812399 · DOI 10.1056/nejmoa0901889