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REFINE ICD - THE NEED FOR THE TRIAL Sudden death prematurely ends hundreds of thousands of lives each and every year. Preventing sudden death requires reliable identification of those at risk, but this has remained elusive due to complexities of predicting sudden death. The implantable cardioverter defibrillator (ICD) has revolutionized the treatment of patients at risk for sudden death. However, current risk assessment approaches fail to identify the majority of patients at risk of sudden, arrhythmic death and simple, practical methods to reduce the incidence of non-essential ICD therapies are needed to enhance recipient outcomes. The Risk Estimation Following Infarction Noninvasive Evaluation - ICD efficacy (REFINE ICD) trial will evaluate whether ICD therapy reduces total mortality compared to usual care in a group of patients with reduced LV function (EF values 0.36 to 0.50) and abnormal non-invasive test results such as an abnormal TWA (T wave alternans) and impaired HRT (heart rate turbulence) enrolled at least 2 months after a myocardial infarction. The Libin Cardiovascular Institute at the University of Calgary is the Clinical Coordinating Centre (CCC) and sponsor of the study. The Clinical Research Unit (CRU) at the Cumming School of Medicine functions as the Data Coordinating Centre. An international Executive Committee has designed this study and will oversee its conduct. An independent Data and Safety Monitoring Committee is providing independent oversight. This is an investigator-initiated and an investigator-run trial with independent support from Alberta Health Services (AHS), Canadian Institutes of Health Research (CIHR), Cardiac Arrhythmia Network of Canada (CANet) and GE Healthcare. The International Executive Committee is comprised solely of clinical researchers. The Executive has full and unrestricted control of the protocol. REFINE ICD is registered at the ClinicalTrials.gov international registry and database and can be accessed at: ► http://clinicaltrials.gov/ct2/show/NCT00673842  |
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