mission statement

The objective of the Telemetric and Holter ECG Warehouse (THEW) is to provide access to continuous electrocardiographic data to for-profit and not-for-profit organizations for the design and validation of analytic methods to advance the field of quantitative electrocardiography with a strong focus on cardiac safety.

05/27/2008:

FDA and University of Rochester signed a collaborative agreement for the THEW.

May 27th 2008, Dr. Janet Woodcock (Director of the Center for Drug Evaluation and Research, FDA) and Dr. Norman Stockbridge (Acting Director of the Division of Cardiovascular and Renal Products, CDER FDA) signed a Letter of Agreement with University of Rochester (UR) for the Telemetric and Holter ECG Warehouse Initiative. This 3-year agreement is accompanied by a fully executed confidentiality disclosure agreement.

This UR-FDA partnership aims at promoting cross-fertilization of scientific knowledge, resources and ideas that will advance the field of quantitative electrocardiography, the THEW will strive to:

  1. Develop specific projects to implement and to grow the repository of ECG information in the THEW;  
  2. Facilitate scientific projects toward the development, testing and validation of ECG-related technologies and platforms;
  3. Leverage expertise and resources toward the implementation of collaborative projects among  FDA, UR, and other public and private stakeholders;
  4. Identify, develop and evaluate new electrocardiographic markers of cardiovascular risk related to management of patient care and evaluation of new molecular entities;
  5. As appropriate, incorporate scientific findings from the THEW into the premarket evaluation process for electrocardiographic devices and associated methodologies, and into the total product life cycle.

The U.S. Food and Drug Administration is interested in the development of improved technologies to evaluate drug safety and efficacy. This interest has been officially expressed in the Critical Path Initiative which is the Agency’s attempt "to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product, or medical device is transformed from a discovery or a "proof of concept" into a medical product”. In the field of drug safety, one approach is to assess the cardiac safety of a new compound by investigating its delaying effect on the QT interval from the surface electrocardiogram (ECG). Today drug-induced QT prolongation is used as a surrogate marker of drug cardiotoxicity, yet the scientific community has strongly questioned its validity and there is a consensus on the need for novel technologies that would improve the current safety guidelines.

In this project, we are developping an international repository for continuous ECG recordings. The objective of  the 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. The legal framework under which the data will be shared is defined in the THEW Data Use Agreement. This agreement is available here.

   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. Currently, several organizations have expressed their interest and have joined this initiative. Members of the THEW will receive the THEW Client Application during summer 2008. 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.


Jean-Philippe Couderc, PhD
Director of the THEW Initiative
Research Associate Professor of Medicine and Electrical Engineering
Heart Research Follow-up Program, Cardiology Department
University of Rochester Medical Center – 601 Elmwood Ave., Box 653
Jean-Philippe.couderc@thew-project.org
Rochester, NY 14642, USA

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