The NHLBI sponsors the Center for quantitative Electrocardiography and Cardiac safety
The Center for Quantitative Electrocardiography and Cardiac Safety and its THEW are fully supported by the NHLBI grant 1R24HL096556.
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.
The University of Rochester and the NHLBI enabled 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 Center hosts the Telemetric and Holter ECG Warehouse. 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.
The mission of the CES and its Telemetric and Holter ECG Warehouse (THEW) is to provide access to continuous electrocardiographic data to for-profit and not-for-profit organizations/entities for the design and validation of analytic methods to advance the field of quantitative electrocardiography with a strong focus on cardiac safety.
In its current state, the THEW includes several large databases of Holter ECG recordings from cardiac patients and healthy individuals. These recordings are fully digital and several of them are annotated. They have been acquired during clinical studies of enrolled subjects that include healthy individuals exposed to cardiac and non-cardiac drugs, patients with congenital long QT syndrome, post-myocardial patients and patients with coronary artery disease . At present, the data available in the THEW is unique. For instance, it includes ECGs documenting drug-induced torsades de pointes in 12-lead Holter ECGs.
We invite not-for-profit and for-profit organizations to contribute to this initiative by becoming members, sharing data, and proposing research projects. No intellectual property restrictions will apply to the use of the THEW databases. For-profit and not-for-profit organizations are invited to use this data to develop new technologies or validate existing ones.
[12/16/2009]: The Director of the THEW interviewed by Technology Review published by the MIT: here.
[11/11/2009]: New Research Center to Focus on Cardiac Safety and Innovation in Pharmaceutical Industry Today: here.
[6/11/2009]: University of of Rochester and FDA Partner for ECG Database, Drug Discovery & Development Magazine. More info here
[5/6/2009] FDA website Existing Partnerships FDA’s Public-Private Partnership Program: THEW
[03/28/2009] Public and Private part- nership to help determine Clinical Biomarker Utility in Applied Clinical Trials online.com.>here
[7/26/2010] Members: Angel Medical System Inc. has joined the THEW initiative. Angel Medical Systems develops and markets cardiac devices that provide heart monitoring, alerting, and data collection. Their AngelMed Guardian system is an iimplantable cardiac monitoring and alerting system that is designed to warn cardiac patients of potentially life-threatening heart conditions.
[7/12/2010] The THEW quoted in a recent issue of the Journal of the American College of Cardiology. In a reply to a correspondence from Dr. Verrier and Nieminen on the role of T-wave alternans in hospital monitoring for torsades de pointes, Dr. Drew quoted the THEW as " a less expensive (than prospective clinical trials) and immediate available research strategy ... to validate ECG monitoring algorithms." JACC Vol. 56, No 3., 23010, 238-42.
[1/13/2010] Members: The Oxford University Computing Laboratory is the first new member for year 2010. At the heart of computing and related interdisciplinary activity at Oxford, this centre focuses on research in computer science, numerical analysis, computational biology, quantum computation, computational linguistics, and information systems. The Computational Biology Group also plays a key role in interdisciplinary initiatives across the University, including the EU FP7 projects euHeart and PreDiCT.
[05/27/2008]: "THEW Beyond QT working Group" releases an ECG marker submission form designed in collaboration with the FDA.
[12/13/2009]:The University of Rochester and the NHLBI enabled the creation of a "Center for Quantitative Electrocardiography and Cardiac Safety" (CES). Read more...
[05/27/2008] FDA: Dr. J. Woodcock (Director, CDER-FDA) and Dr. Norman Stockbridge (Director for the Division of Cardiovascular and Renal Products, CDER-FDA) signed a Letter of Agreement officially starting the partnership between the FDA and University of Rochester for the THEW initiative. More...
