Cleerly to Present Late-Breaking Results from the First Randomized Trial of AI-QCT-Guided Care in Patients with Stable Chest Pain at AHA 2026
Primary results from PARAMOUNT, comparing plaque-based care with usual care in patients with suspected coronary artery
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Cleerly, a leader in AI-based cardiovascular imaging, announces its participation in the American Heart Association (AHA) Scientific Sessions 2026, November 6 to 9 at McCormick Place Convention Center in Chicago, Illinois. Cleerly will share primary results from PARAMOUNT, the first randomized trial to compare personalized care guided by AI-based quantitative coronary CT analysis (AI-QCT) with usual care in symptomatic patients with suspected coronary artery disease (CAD). Onsite, the Cleerly team will demonstrate AI-QCT, which gives physicians a detailed, quantitative view of coronary plaque to support their clinical decisions.
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On Saturday, November 7, at 9:45 a.m. Todd C. Villines, MD, of the University of Virginia, will present the primary results of PARAMOUNT on behalf of the trial investigators.
Late-Breaking Science Presentation
On Saturday, November 7, at 9:45 a.m. Todd C. Villines, MD, of the University of Virginia, will present the primary results of PARAMOUNT on behalf of the trial investigators. His presentation is part of the Late-Breaking Science session “Stable Ischemic Heart Disease: What Happens in the Long Run” in Learning Studio 2. Results are under embargo until the time of presentation.
PARAMOUNT is a clinical strategy trial that randomized 530 patients with stable chest pain at 21 sites across the US, designed to determine whether AI-QCT-enabled Cleerly PLAQUE and ISCHEMIA assessment and staging guides caregivers to improve medical and interventional management in patients with stable chest pain as compared to usual care over 180 days of follow-up.
“We are thrilled that PARAMOUNT is the first randomized trial in which care teams were assisted by Cleerly’s AI technology to assess both coronary atherosclerosis and myocardial ischemia and to use those insights in medical and interventional care,” said Udo Hoffmann, MD, MPH, Chief Medical, Scientific, and AI Officer at Cleerly and a PARAMOUNT author. He added, “While traditional care is focused on detecting and reconstituting flow limiting coronary lesions, PARAMOUNT will assess a new paradigm of ‘Diagnosing, Staging and Treating’ CAD to unlock the benefits of both medical and interventional care for our patients. We’re excited to share these results with the cardiovascular community, and we invite everyone at AHA to join Dr. Villines on Saturday morning.”
TRANSFORM Session
On Saturday, November 7, from 3:15 to 4:00 p.m. CT in Learning Studio 3, TRANSFORM investigators will discuss diagnosing, staging, and treating CAD. The panel includes Deepak L. Bhatt, MD, MPH, MBA, of Mount Sinai Fuster Heart Hospital; Marc P. Bonaca, MD, MPH, of CPC and the University of Colorado School of Medicine; Dr. Hoffmann; and Pam R. Taub, MD, of UC San Diego Health. Attendees are welcome to enjoy complimentary healthy snack boxes and beverages during the session.
TRANSFORM is a randomized, event-driven outcomes trial evaluating an AI-guided approach to staging and treating CAD in asymptomatic patients at increased risk for heart attacks. The trial is testing whether care guided by Cleerly’s investigational Coronary Artery Disease Staging System reduces heart attacks and other cardiovascular events as compared to usual prevention based on traditional risk factors alone. TRANSFORM is active at 125 sites across the US, and primary results are anticipated in 2029. Note that this event is not part of the official Scientific Sessions Conference 2026 as planned by the American Heart Association Committee on Scientific Sessions Programming.
Visit Cleerly at HIPod 8
Stop by HIPod 8 in the Health Innovation Pavilion, November 7 to 9, to see live demonstrations of how AI-QCT plaque analysis fits into clinical workflow. To see Cleerly’s full schedule or book a meeting with Cleerly leadership, visit www.cleerly.com/events/aha-2026.
About Cleerly
Cleerly is the company on a mission to eliminate heart attacks by creating a new standard of care for heart disease. Through its FDA-cleared solutions driven by artificial intelligence, Cleerly supports comprehensive phenotyping of coronary artery disease, as determined from advanced noninvasive CT imaging. Cleerly’s approach is grounded in science, based on millions of images from over 40,000 patients. Led by a world-class clinical and technical team, Cleerly enhances health literacy for each and every stakeholder in the coronary care pathway. For more information, please visit: cleerlyhealth.com.
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