URMC, FDA to collaborate on national data repository for heart research

The University of Rochester Medical Center (URMC) will collaborate with the U.S. Food and Drug Administration (FDA) to develop a national repository of data that will aid academic and industry researchers studying the electrical activity of the heart. In addition to helping researchers understand many cardiac problems, the data may aid the development of new tools to detect drugs that can have dangerous effects on the heart.

The repository will include thousands of electrocardiogram (ECG) recordings from cardiac patients and healthy volunteers who have worn small devices to monitor their heart activity, usually for hours or days at a time. It includes ECG recordings of rare events, including dangerous heart-rhythm problems that were triggered by certain drugs.

Researchers at URMC have been collecting and studying the ECG data for decades through the university's Heart Research Follow-Up Program. The data repository, which will be owned and maintained by URMC, will be called the Telemetric and Holter Electrocardiogram Warehouse, or THEW. An agreement signed by URMC and FDA establishes both parties' intent to work together, under the auspices of a public-private partnership, to use the THEW data to address public health needs in the area of cardiac safety.

Access to the THEW data by outside researchers will be governed by an executive committee that includes representatives from URMC, FDA, industry, academia, and other stakeholders. Representatives from FDA will provide scientific input on research projects aimed at improving drug safety, such as identifying patterns in ECG data that reveal drug side effects, and the development of computer software that scan large amounts of ECG data to spot those patterns.

"The goal of this program is to give companies and not-for-profit organizations the ability to develop and validate new technologies and advance the field of quantitative electrocardiology," said URMC biomedical engineer Jean-Philippe Couderc, Ph.D., the director of the THEW project. "Current methods of measuring a drug's potential toxicity to the heart are insufficient. Scientists need access to more data so they can develop a better picture of what is going on in patients across time so we can do better measurements with more precision."