Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00157768
Status:
COMPLETED
Last Update Posted:
2018-10-09
First Post:
2005-09-08
Brief Title:
IRIS Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Sponsor:
Medtronic Bakken Research Center
Organization:
Medtronic Bakken Research Center
Study Overview
Official Title:
IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians ALKK
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IIII A positive effect of beta-blockers Metoprolol CRZok 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None