ECG and Electrophysiology Core Laboratory Services The Heart Research Follow-up Program (HRFUP) has been involved in electrocardiology research for over 20 years. The main focus of this research is on ventricular arrhythmias and ventricular repolarization analyses. The HRFUP ECG core laboratory is prepared to conduct analysis of all types of ECG recordings including standard 12-lead ECG, signal-averaged ECG (SAECG), digital high resolution ECG, and analog or digital long-term 24-hour Holter recordings. Over several years of conducting the NIH and industry sponsored large clinical studies and trials, the HRFUP has developed expertise in the central coordination and analysis of ECG recordings. We are pleased to inform you that our research-oriented ECG Core Lab at Heart Research Follow-up Program of Cardiology Unit is broadening the spectrum of its activity. Our ECG Core Lab is actively involved in various clinical and animal ECG studies requiring central management of ECG data acquisition, central reading and analysis of ECGs in various technical forms. The analysis of paper-copy ECGs, with particular emphasis on QT interval evaluation, is our routine activity related to specific research or drug-safety oriented projects. In the current era of digital ECG technology, we are fully operational managing data acquisition and analysis of digital standard 12-lead ECG and 24-hour Holter ECG recordings utilizing the state-of-the-art methodologies. Clinical Research Experience The HRFUP has served as central ECG, Holter, and SAECG core laboratory for several large NIH, EPA, HEI sponsored studies including: Long QT Syndrome: Population, Genetic and Cardiac Studies Genetics, Mechanisms and Clinical Phenotypes of Arrhythmogenic Cardiomyopathy Multicenter Postcoronary Risk Stratification Program Multicenter Study of Silent Myocardial Ischemia Thrombogenic Factors and Recurrent Coronary Events Effect of air pollution on ECG parameters in animal, human exposure, and epidemiological studies Effect of Raloxifen on Repolarization Effect of Flecainide on Repolarization in LQT3 Patients Analysis of ECG changes in LQT2 Patients Ranolazine ICD Trial Interest of IKr-related Abnormalities of ECGs to Improve Drug-safety Evaluation Risk-Stratification of Patients with the Long QT Syndrome (LQTS) based on Holter Recordings QT-RR Dynamic Coupling in Patients with the Long QT Syndrome as well as corporate sponsored studies including: Multicenter Diltiazem Postinfarction Trial (Marion Laboratories) Multicenter Automatic Defibrillator Implantation Trial (CPI/Guidant) Repolarization Analysis in Diphenhydramine Overdose Patients (Warner Lambert) Intercity Digital Electrocardiology Alliance (Burdick) Repolarization Analysis in Patients Treated with Mibefradil (Hoffman LaRoche) Multicenter Automatic Defibrillator Implantation Trial II (CPI/Guidant) Dynamic Aspects of repolarization (Ela Medical, Sanofi-Synthelabo) Next Generation INCEPTA ICD and CRT-D Field Following Study: Respiratory Rate Trend Evaluation in Heart Failure Patients (Guidant/Boston Scientific) Study of the Wearable Defibrillator: In Advanced Heart Failure Patients (LifeCor) Wearable Cardiac Defibrillator Study in Hemodialysis Study (LifeCor) Ranolazine in LQT3 Patients (Gilead Sciences) LQT3 Registry (Gilead Sciences) Multicenter Automatic Defibrillator Implantation Trial: Chemotherapy-Induced Cardiomyopathy (Guidant/Boston Scientific) A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Dose Ranging, Parallel Group Study to Evaluate the Effect of GS-6615 on Ventricular Arrhythmia in Subjects with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (Gilead Sciences) A Phase 2, Proof of Concept, Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Ranolazine and Dronedarone When Given Alone and in Combination on Atrial Fibrillation Burden in Subjects with Paroxysmal Atrial Fibrillation (Gilead Sciences) An Open-label Study to Evaluate the Effect of Single Dose GS-6615 on QT, Safety and Tolerability in Subjects with Long QT-3 Syndrome (Gilead Sciences) Facility Description The HRFUP experience is based on analysis of thousands paper and digital ECGs, and Holter recordings. The HRFUP is fully equipped and prepared to conduct computer analyses of various high-resolution and long-term digital ECG recordings. The HRFUP has developed award-winning computer programs that interpret various aspects of ECG changes including, but not limited to, repolarization analysis in standard and long-term recordings, atrial and ventricular arrhythmia analyses, ST - T segment evaluation, P-wave and QRS signal-averaging, and heart rate variability analyses. The HRFUP ECG analytic facilities are merged with a central computer clinical data management system that has been developed and validated over a period of 20 years. The HRFUP has direct access to world class biostatisticians with vast experience in project design and analysis. Investigator Experiences Jean-Philippe Couderc, Ph.D., MBA – Director of ECG Core Lab, Assistant Director of the HRFUP, and Associate Professor of Medicine (Cardiology), Research Associate Professor of Electrical and Computer Engineering (UR College) is biomedical engineer with extensive experience in ECG signal processing. He has patented and licensed multiple technologies developed at UR. Dr. Couderc is the scientific founder of a local startup company and the Director of the Center for Quantitative Electrocardiography and Cardiac Safety. Wojciech Zareba, M.D., Ph.D. - Director of the HRFUP and Professor of Medicine and Professor of Environmental Medicine who has been Principal Investigator of several clinical cardiology studies focused on ventricular arrhythmias and sudden death and studies advancing filed of electrocardiology. Dr. Zareba also oversees clinical research in the UR Cardiology Division as Director of Cardiology Clinical Research. Arthur J. Moss, M.D. – Former Director and Founder of the HRFUP and Professor of Medicine who has been Principal Investigator of numerous pivotal clinical studies and trial in clinical cardiology. Studies conducted by Dr. Moss led to new indications for implantable cardioverter-defibrillators exercised in thousands of patients worldwide. Mary Brown, M.S. – Program Manager of the HRFUP, who coordinates the administrative activities and data management. Michal Weiss, MPH – Manager of the ECG Core Lab, who coordinates daily activities of the core lab This activity is supported by computer programmers operating a computer relational database and fully trained ECG technicians. This activity is supported by computer programmers operating a computer relational database and fully trained ECG technicians.