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

Acute Myocardial Infarction Clinical Trial

Official title:

IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00157768
• Other study ID #: Medtronic_BRC_CRM_002
• Status: Completed
• Phase: Phase 4
• Start date: June 9, 1999
• Est. completion date: October 15, 2007

Study information

• Verified date: October 2018
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: October 15, 2007
• Est. primary completion date: October 15, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Implantable cardioverter defibrillator

Locations

Country	Name	City	State
Netherlands	Medtronic Bakken Research Center B.V.	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center	AstraZeneca

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,
Secondary	Device-related complications, Hospitalizations, Quality of life