Pediatric cardiac screening data warehouse created
The Cardiac Safety Research Consortium announced that a pediatric cardiac screening data warehouse has been created and prospective data collection is underway.
Researchers started prospectively collecting data for the Prevention of Sudden Cardiac Death in the Young (SCDY) National Cardiac Screening Warehouse Pilot Study in May 2021, and more than 40,000 ECGs collected from 2015 to 2021 were added to the warehouse, which was created by the FDA, Duke University and other organizations, according to a press release from the consortium.
A comparable ECG warehouse exists for the FDA to support cardiac safety review in adults, but this the first time such data for children are available to the agency, according to the release.
“This warehouse has the potential to address two major unmet public health needs — identification of children at risk for SCDY and enhanced cardiac safety in pediatric drug development,” Salim F. Idriss, MD, PhD, executive co-director of the Duke Pediatric and Congenital Heart Center and director of pediatric electrophysiology at Duke University Medical Center, who is principal investigator of the project, said in the release. “Thanks to the support of our industry and academic partners and especially our collaborating public screening groups, many of whom are parent-led foundations with limited funding, we have improved the efficiency and quality of ECG data collection, leading to an unprecedented volume of reliable real-world data. We now have the ability to begin establishing pediatric ECG interpretation normal values based on sex, race and ethnicity, in addition to the current values used for age, based on these data alone.”