Cardiac safety remains a major public health concern. Sudden cardiac death (SCD) for instance, is responsible for half of all heart disease deaths and is the largest cause of natural death in the U.S. (representing about 325,000 adults each year). Despite the effort implemented to reduce this number by early advanced care, there is a clear need for the improvement of risk stratification techniques to optimize the use of prophylactic therapies such as implantable defibrillators and drug therapies. Meanwhile cardiac safety is also one of the most challenging hurdles in the development of new molecular entities. It has been estimated that as many as 86% of all drugs tested in pharmaceutical development show specific inhibitory activity of potassium ion kinetics which in some cases can lead to torsades de pointes and potentially to SCD. According to the US Food and Drug Administration (FDA), the main reason for the inability of the current pharmaceutical to effectively screen out potentially harmful drugs is the lack of better markers to improve predictability and efficacy of new compounds. The roles of the surface electrocardiograms (ECGs) as a noninvasive approach to assess drug cardiotoxicity, to predict arrhythmic events, and to risk stratify cardiac and non-cardiac patients represent a matter of paramount importance. We propose to the NHLBI to enable the creation of a """"""""Center for Quantitative Electrocardiography and Cardiac Safety"""""""" (CES) by supporting its inceptive activities around 1) the development and maintenance of computer resources (data storage and computing center), 2) the deployment of medical information and 3) the formation of a scientific network. The CES will host the Telemetric and Holter ECG Warehouse, an initiative currently implemented by a working group consisting of staff members from the FDA, the University of Rochester and its Medical Center. The CES will distribute these resources to the International scientific community, sharing unique clinical and ECG information for the design and validation of technologies to improve quantitative electrocardiography and cardiac safety.
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