NCT00157768

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 1999

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 9, 1999

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2007

Completed
Last Updated

July 3, 2025

Status Verified

October 1, 2018

Enrollment Period

8.4 years

First QC Date

September 8, 2005

Last Update Submit

June 30, 2025

Conditions

Acute Myocardial Infarction

Keywords

Acute myocardial infarctionNon-sustained ventricular tachycardiaLeft ventricular dysfunctionImplantable cardioverter defibrillatorICDRisk-stratification

Outcome Measures

Primary Outcomes (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.

Secondary Outcomes (2)

  • Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,

  • Device-related complications, Hospitalizations, Quality of life

Interventions

Implantable cardioverter defibrillatorDEVICE

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medtronic Bakken Research Center B.V.

Maastricht, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 19812399DERIVED

MeSH Terms

Conditions

Ventricular Dysfunction, Left

Interventions

Defibrillators, Implantable

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

DefibrillatorsElectrodesElectrical Equipment and SuppliesEquipment and SuppliesElectrodes, ImplantedProstheses and Implants

Study Officials

  • D. Andresen, Prof.

    Klinikum am Urban, Berlin, Germany

    PRINCIPAL INVESTIGATOR

  • J. Senges, Prof.

    Herzzentrum Ludwigshafen, Germany

    PRINCIPAL INVESTIGATOR

  • G. Steinbeck, Prof.

    Klinikum Grosshadern, Munich, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 9, 1999

Primary Completion

October 15, 2007

Study Completion

October 15, 2007

Last Updated

July 3, 2025

Record last verified: 2018-10

Locations

NL(1)