FDA, industry, and patient advocacy groups join effort to advance effective cardiac screening
Durham, NC, October 15, 2020 – The Cardiac Safety Research Consortium (CSRC) announces the establishment of a first-in-kind national database of pediatric cardiac screening information aimed at advancing the ability to discover potentially dangerous pediatric cardiac conditions and preventing sudden cardiac arrest or death in young people (SCDY). This database is being developed through a multidisciplinary partnership formed by the CSRC with support from the U.S. Food and Drug Administration (FDA) with the goal of identifying and overcoming barriers to effective pediatric cardiac screening.
“For the first time, we will have access to high-quality pediatric data on a scale that will allow us to further research a wide array of cardiac issues facing children – from sudden cardiac arrest to cardiac side effects of drugs to the cardiac effects of having had a COVID-19 infection,” explained the project’s principal investigator, Salim F. Idriss, MD, PhD, executive co-director of the Duke Pediatric and Adult Congenital Heart Center and director of pediatric electrophysiology at Duke University Medical Center. “Establishing a scalable, reliable national warehouse of pediatric cardiac screening data, including metrics such as data completeness, ECG interpretability, and assessment of long and short-term follow up, is the key to improved cardiac care in this population.”
“CSRC’s mission is to drive collaboration among public health, academia, government and industry experts to address complex cardiac safety issues,” said Jonathan Seltzer, MD, MBA, FACC, executive director of the CSRC. “This database is a prime example of how collaboration can fast-forward research for a pressing public health problem.”
Ten community screening organizations from across the country have been recruited to date as partners to help establish the national data warehouse. The organizations were recruited through national project partner, Parent Heart Watch, whose prevention-driven initiatives include cultivating local champions who create community programs focused on the prevention of SCDY. Parent Heart Watch anticipates actionable outcomes from this collaboration, in particular, converting research into strategies that affect systemic change in pediatric primary care protocol. “At the heart of our movement is the knowledge that sudden cardiac death can be prevented,” explained Martha Lopez-Anderson, executive director. “This project fully aligns with our mission to ultimately empower medical practitioners and families to recognize warning signs and risk factors before tragedy strikes—it’s truly a life-saving initiative.”
In addition to Parent Heart Watch, current partners include:
- Community screening organizations including: Championship Hearts Foundation (Texas), Cody Stephens Go Big or Go Home Memorial Foundation (Texas), Saving Hearts Foundation (California), Eric Paredes Save A Life Foundation (California), Screening America (South Dakota), Heart Screen New York (New York), Peyton Walker Foundation (Pennsylvania), Hearts for Athletes (Alabama), Thomas Smith Memorial Foundation (Michigan), Play for Jake Foundation (Indiana)
- Academic leaders from Children’s Hospital of Philadelphia, Lurie Children’s Hospital, Cleveland Clinic Lerner College of Medicine, and Baylor College of Medicine
- Industry partners including: AMPS LLC (Analyzing Medical Parameters for Solutions), AstraZeneca, Cardiac Insight Inc., Eli Lily, ERT, and IQVIA
The study is ongoing, and anyone interested in supporting the initiative is encouraged to contact CSRC about how to get involved. “Partnership is essential to this effort, and we welcome others who are interested in lending their support – financial or otherwise – to the study,” Dr. Idriss added.
About Cardiac Safety Research Consortium
The Cardiac Safety Research Consortium (CSRC) provides leadership and guidance for regulators, public and private clinical researchers, and industry through an open, interactive forum to collectively address cardiovascular related issues in clinical trials for both new and existing products. The organization offers unique resources and a collaborative structure that allows for valuable contributions to scientific study design, data analysis and interpretation, and dissemination to the public. CSRC’s non-competitive environment allows for experts to engage in a rigorous, transparent process to define an optimal path forward in the advancement of cardiac safety research, knowledge, and excellence. The impact of CSRC and the thought leadership of its members on key cardiac safety research issues has a proven track record of benefiting the global scientific and regulatory community. For more information about CSRC, visit their website or email firstname.lastname@example.org.