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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Implantable cardioverter defibrillator
Sponsored by
Medtronic Bakken Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Non-sustained ventricular tachycardia, Left ventricular dysfunction, Implantable cardioverter defibrillator, ICD, Risk-stratification

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medtronic Bakken Research Center B.V.

Outcomes

Primary Outcome Measures

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 Outcome Measures

Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Device-related complications, Hospitalizations, Quality of life

Full Information

First Posted
September 8, 2005
Last Updated
October 5, 2018
Sponsor
Medtronic Bakken Research Center
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00157768
Brief Title
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Official Title
IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 9, 1999 (Actual)
Primary Completion Date
October 15, 2007 (Actual)
Study Completion Date
October 15, 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medtronic Bakken Research Center
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Acute myocardial infarction, Non-sustained ventricular tachycardia, Left ventricular dysfunction, Implantable cardioverter defibrillator, ICD, Risk-stratification

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
900 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Implantable cardioverter defibrillator
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Title
Device-related complications, Hospitalizations, Quality of life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D. Andresen, Prof.
Organizational Affiliation
Klinikum am Urban, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
J. Senges, Prof.
Organizational Affiliation
Herzzentrum Ludwigshafen, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
G. Steinbeck, Prof.
Organizational Affiliation
Klinikum Grosshadern, Munich, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medtronic Bakken Research Center B.V.
City
Maastricht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
19812399
Citation
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.
Results Reference
derived

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

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