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New Research Center to Focus on Cardiac Safety and Innovation
Date:11/11/2009

ROCHESTER, N.Y., Nov. 11 /PRNewswire-USNewswire/ -- The University of Rochester Medical Center has announced the creation of a new center that will assist researchers studying the electrical activity of the heart with the goal of improving drug safety, understanding cardiac arrhythmias, and developing new electrocardiograph technologies. The Center for Quantitative Electrocardiology and Cardiac Safety -- funded by a $2.3 million grant from the National Institutes of Health -- brings together an international network of academic researchers, pharmaceutical and medical device companies, and government regulators.

"Cardiac toxicity is one of the leading causes of removal of drugs from the market," said University of Rochester biomedical engineer Jean-Philippe Couderc, Ph.D., the director of the new Center. "The goal of this initiative is to foster collaboration on an international scale and support research that will ultimately improve cardiac safety."

The new Center will focus on developing novel methods and new technologies to evaluate electrocardiographs (ECG) for the purposes of predicting cardiac arrhythmias. The Center's unique resources will help scientists better understand heart disease and determine whether or not experimental drugs are toxic to the heart. Sudden cardiac arrest is one of the leading causes of death and many of these incidents are drug-related -- either caused by the drugs themselves or because a drug triggered a predisposition to lethal cardiac arrhythmias.

In 2004, the Food and Drug Administration (FDA) launched the Critical Path Initiative, an effort to accelerate the process of bringing medical breakthroughs to patients while at the same time ensuring safety and reducing drug development costs. One of the goals of this initiative was to develop better ways to determine a drug's potential cardiac toxicity before it is brought to market. The FDA requires a thorough analysis of the impact of experimental drugs on cardiac activity, but it is acknowledged that current methods can be improved.

Last year, the FDA partnered with the University of Rochester to create an electronic database of ECG data to help foster research in this field. The Telemetric Holter Electrocardiograph Warehouse (THEW) -- which now forms the core of the new Center -- consists of thousands of recordings from individuals with cardiac arrhythmias, healthy volunteers, individuals with drug induced cardiac events, individuals participating in clinical trials, and rare cardiac events. This data comes from individuals who have worn cardiac monitoring devices to record their heart activity, usually for hours or days at a time. For more information about the creation of the THEW database visit: http://www.urmc.rochester.edu/news/story/index.cfm?id=2685.

This data will be provided to academic and private research organizations to help them design and validate new tools and methods to detect abnormal cardiac activity. The Center will also serve as a bridge between researchers and federal regulators to help facilitate the development of new technologies that can improve safety and reliability of information from clinical trials.

"The Center represents probably the first opportunity in the history of cardiac safety where data of this scale and value has been gathered together and made available to academic and industry researchers," said Couderc. "At the same time, these resources will help support a scientific network in which ideas and concept related to ECG technologies can be discussed and implemented with the input from representatives from the National Institutes of Health and the FDA."

The Center is an outgrowth of the University of Rochester's Heart Research Follow-Up Program which has been a leader in the science of heart arrhythmias for over 20 years. The program maintains an international registry of individuals with a rare inherited syndrome that is similar to drug induced cardiac events.

To date, the project has received ECG data from pharmaceutical companies Pfizer and Roche and Munich University in Germany. Academic research partners include the University of Minnesota, University of Utah, Masonic Medical Research Laboratory in Utica, New York, Stony Brook University, University of California San Francisco, Lariboisiere Hospital in Paris, University of Milan, Eramus Medical Center in the Netherlands, University of Applied Sciences in Germany, Louis Pradel Hospital and INSA in Lyon, France, Lund University Hospital in Sweden, the Academy of Science of the Czech Republic, and the University of Zaragoza in Spain.

For more information about the initiative, visit: http://www.thew-project.org.

One of the nation's top academic medical centers, the University of Rochester Medical Center (http://www.urmc.rochester.edu) forms the centerpiece of the University's health research, teaching, patient care, and community outreach missions. The Medical Center receives more than $230 million in external research funding per year and the University of Rochester School of Medicine and Dentistry ranks in the top one-quarter of U.S. medical centers in federal research funding. The University's health care delivery network is anchored by Strong Memorial Hospital -- a 739-bed, University-owned teaching hospital. As upstate New York's premier health care delivery network, patients benefit from the Medical Center's robust teaching and biomedical research programs.

SOURCE University of Rochester Medical Center


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SOURCE University of Rochester Medical Center
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