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Enhanced level of QT analysis offers sponsors a more complete foundation to establish drug safety.
Washington, DC-Cardiocore, a centralized cardiac testing lab, announced today that it has accomplished significant advancements in the Holter Bin Methodology for ECG data analysis. Cardiocore’s technology and processes isolate heart rate-related QT effects, thereby reducing the potential for false positive outcomes in Thorough QT studies.
Cardiocore Chief Medical Officer, Lawrence Satin, MD, FACC has been invited to discuss these developments at the FDA’s Cardiovascular Safety, QT, and Arrhythmia in Drug Development conference, on April 29-30, in Bethesda, MD.
Dr. Satin’s presentation will demonstrate how the Holter Bin method highlights distinctions between various causes of QT prolongation. This enhanced level of QT analysis may be valuable to many Thorough QT study sponsors.
“We are very proud to provide our clients this advanced scientific service in their cardiac safety trials,” said Dr. Satin. He continued, “Particularly for drug developers who’s compound may affect heart rate, this methodology provides a clearer and more complete foundation to establish their drug’s safety profile.”
Cardiocore Vice President of Medical Operations, Polina Voloshko, MD added, “To properly apply the Holter Bin technique, important intricacies such as time-matching and hysteresis management must be addressed. Cardiocore has resolved these issues by deploying sophisticated technologies and by applying a full understanding of the test drug’s pharmacokinetic profile into the protocol design.”
In support of Cardiocore’s Holter Bin service, well-known cardiac testing technology provider, AMPS, has customized its newly upgraded WinAtrec application for seamless integration into Cardiocore’s advanced cardiac data management platform.
As a secondary endpoint in a Thorough QT study, this Holter Bin solution complements the mathematical formulas traditionally used to mitigate the affect of heart rate variability on QT analysis. Heart beats are organized into “bins” of similar heart rate. Measurements from one beat are compared to those from other beats within the same bin. The resulting data distinguishes potentially fatal forms of QT prolongation—those caused by ion channel blockade—from less-troubling types of QT prolongation caused by heart rate fluctuation.
More information about Cardiocore’s scientific expertise, data management system, and sponsor-benefiting Holter solutions are available at the company’s web site, http://www.cardiocare.com/