IRIS : Use of Implantable Defibrillator in High-Risk Patients Early After Acute Myocardial Infarction
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.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Conditions
Acute Myocardial Infarction
Intervention
Implantable cardioverter defibrillator
Location
Medtronic Bakken Research Center B.V.
Maastricht
Netherlands
Status
Active, not recruiting
Source
Medtronic Bakken Research Center
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00157768
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Anterior Wall Myocardial Infarction
MYOCARDIAL INFARCTION in which the anterior wall of the heart is involved. Anterior wall myocardial infarction is often caused by occlusion of the left anterior descending coronary artery. It can be categorized as anteroseptal or anterolateral wall myocardial infarction.
Acute Coronary Syndrome
An episode of MYOCARDIAL ISCHEMIA that generally lasts longer than a transient anginal episode but that does not usually result in MYOCARDIAL INFARCTION.
Inferior Wall Myocardial Infarction
MYOCARDIAL INFARCTION in which the inferior wall of the heart is involved. It is often caused by occlusion of the right coronary artery.
Heart-assist Devices
Small pumps, often implantable, designed for temporarily assisting the heart, usually the left ventricle, to pump blood; they consist of a pumping chamber and a power source, which may be partially or totally external to the body and activated by electromagnetic motors; the devices are used after myocardial infarction or to wean the repaired heart from the heart-lung machine after open-heart surgery.
Nitric Oxide Donors
A diverse group of agents, with unique chemical structures and biochemical requirements, which generate NITRIC OXIDE. These compounds have been used in the treatment of cardiovascular diseases and the management of acute myocardial infarction, acute and chronic congestive heart failure, and surgical control of blood pressure. (Adv Pharmacol 1995;34:361-81)
Clinical Trials
Further Acute Research of a Subcutaneous Implantable Defibrillator (S-ICD) System
The purpose is to further evaluate the operation, safety, and feasibility of a subcutaneous implantable defibrillator (S-ICD) system in patients who require an implantable cardioverter def...
Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A clos...
SecuraTM ICD Clinical Evaluation Study
The purpose of the Secura clinical study is to evaluate the overall system safety and clinical performance of the Secura DR Implantable Cardioverter Defibrillator (ICD)
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchroni...
The completed MADIT II study has shown that implantation of a cardioverter-defibrillator (ICD) in patients with a reduced left ventricular ejection fraction and a prior myocardial infarcti...
PubMed Articles
Background- Although implantable cardioverter-defibrillators (ICDs) lower mortality in stable patients with low ejection fraction late after myocardial infarction, randomized trials of ICD versus cont...
The aim of this study was to compare single- versus dual-chamber implantable cardioverter-defibrillator (ICD) implantation and complication rates in a large, real-world population.
Dramatic reductions in the rate of sudden cardiac death due to use of implantable cardioverter-defibrillators (ICDs) have been well-established in several large randomized clinical trials including pa...
The purpose of this study was to evaluate the impact of upgrading implantable cardioverter-defibrillator (ICD) therapy to cardiac resynchronization therapy (CRT) combined with defibrillator (CRT-D) on...
The purpose of this study is to assess the effectiveness of defibrillation testing (DT) in patients undergoing implantable cardioverter-defibrillator (ICD) insertion.
