New Center For Cardiac Safety And Innovation Launched By URMC

Main Category: Cardiovascular / Cardiology
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials;  Regulatory Affairs / Drug Approvals
Article Date: 13 Nov 2009 - 0:00 PST

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The University of Rochester Medical Center (URMC) 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 URMC 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 - 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.

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. They 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, Lariboisière 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.

Source: Mark Michaud
University of Rochester Medical Center