HeartFlow has launched a new data registry focused on Plaque Analysis, the company’s advanced artificial intelligence (AI) offering for patients with suspected coronary artery disease (CAD).
Plaque Analysis, designed to evaluate signs of coronary plaque identified in coronary CT angiography (CCTA) scans, received U.S. Food and Drug Administration approval back in October 2022. The DECIDE Registry will examine how patient outcomes are impacted by treatment with the advanced AI model. HeartFlow hopes to gain a better understanding of how it influences clinician decision-making, for example, especially when compared with treatment that does not involve the use of Plaque Analysis.
One site, Cone Health Care, has already committed to participating in the DECIDE Registry; the goal is to recruit 25 sites and compile data from approximately 10,000 patients with suspected CAD.
Leslee Shaw, PhD, a professor of medicine and director of the Blavatnik Family Women’s Health Research Institute at Icahn School of Medicine at Mount Sinai, and Sarah Rinehart, MD, medical director of cardiovascular imaging, CT and nuclear at Charleston Area Medical Center, will serve as the registry’s co-lead investigators.
“CAD remains one of the leading causes of death in the United States,” Shaw said in a statement. “While treatment options for the disease have improved over time, the complexity of the disease still leaves opportunity to enhance diagnostic and treatment protocols. The DECIDE Registry has the potential to improve how coronary artery disease is diagnosed and set a new standard of care in cardiovascular care driving positive change in population health overall.”
Early research on the effectiveness of HeartFlow’s Plaque Analysis tool has been positive. According to new research published in the Journal of the Society for Cardiovascular Angiography & Interventions, for example, Rinehart et al. found that Plaque Analysis was associated with impacting the decisions of clinicians in 66% of cases.[1] Also, nearly 50% of patients with a calcium score of zero were reclassified after Plaque Analysis was used, highlighting its ability to provide additional insights.
“We believe real-world prospective data from the new DECIDE Registry will empower clinicians with enhanced patient insights leveraging HeartFlow Plaque Analysis to improve patient outcomes,” John Farquhar, HeartFlow CEO, said in the same statement. “The DECIDE Registry underscores the rigor of HeartFlow’s clinical portfolio, with an intentional study design to offer meaningful insights.”
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.