Enrollment Underway in Elucid’s Study to Define Lesion-Level Cardiovascular Risk

Elucid has begun enrolling patients in AI-PREDICT, a retrospective, international, multicenter study that aims to establish a new lesion-centric paradigm for cardiovascular risk stratification.

Enrollment is underway at three of more than 20 planned sites across the United States, Europe, and Asia: Emory University, the Medical University of South Carolina, and Centro Cardiologico Monzino, Milan, led by site principal investigators Carlo N. De Cecco, M.D., Ph.D.; Akos Varga-Szemes, M.D., Ph.D.; and Gianluca Pontone, M.D., Ph.D., respectively.

AI-PREDICT will enroll approximately 1,000 subjects, including both patients who experienced a myocardial infarction (MI) within 36 months of a baseline coronary CT angiography (CCTA) and clinically matched, event-free controls, generating a dataset of individual coronary lesions. All scans will be analyzed by a central core lab, blinded to outcomes, using Elucid’s Plaque-IQ and FFR-CT¹ software to measure key morphological, anatomical, and physiological features.

“We joined AI-PREDICT early because it asks the question: among the many plaques in a patient, which features distinguish the one plaque that causes harm from the many that don’t? This study expects to extract that detail lesion by lesion, which is why we wanted to be part of AI-PREDICT,” Dr. Pontone stated.

Heart disease remains the leading cause of death globally.² Despite massive investment in cardiovascular medicine,³ the problem persists due in part to limitations of traditional diagnostic methodologies.⁴ Many heart attacks arise from plaques that progressed silently, in the moderate stenosis range, producing no symptoms before causing the problem.⁵ The AI-PREDICT study is designed to better identify and stratify those lesions in advance.

The AI-PREDICT study is led by a team of internationally recognized cardiovascular scientists and imaging specialists. The principal investigator is Jagat Narula, M.D., Ph.D., president of the World Heart Federation and one of the world’s foremost authorities on cardiovascular imaging and plaque biology. The co-principal investigator is Dr. De Cecco, professor of Radiology and Biomedical Informatics and director of the Cardiothoracic Imaging Division at Emory University School of Medicine, whose work has advanced the use of AI and quantitative imaging in cardiac CT. The study’s Steering Committee is co-chaired by Amir Ahmadi, M.D., clinical associate professor of medicine (cardiology) at the Icahn School of Medicine at Mount Sinai, and lead scientific advisor at Elucid, and Michael Hadley, M.D., system director of Advanced Cardiac Imaging at Northwell Health, an expert in cardiac CT and its clinical applications.

“AI-PREDICT represents a fundamental shift in how we think about cardiovascular risk,” Dr. Narula said. “For too long, we have assessed risk at the population level while heart attacks happen at the lesion level. This study is designed to take a step towards closing that gap.”

“By comparing culprit lesions and non-culprit bystander lesions in the same MI patient, and stable lesions in matched controls, we will, for the first time, have a rigorous, large-scale framework for understanding risk at a lesion level. This could be key in guiding personalized CAD prevention,” Dr. Ahmadi added.

AI-PREDICT reflects Elucid’s efforts to move cardiovascular care towards CCTA 3.0, the company’s vision for personalized, lesion-level care.

Elucid is a Boston-based medical technology company that develops artificial intelligence (AI) to see invisible features of cardiovascular risk. The company is developing a clinical platform to help physicians deliver CCTA-guided personalized care by providing a more precise view of atherosclerosis, the root cause of cardiovascular disease. The company’s U.S. Food and Drug Administration-cleared Plaque-IQ image analysis software helps physicians prioritize and personalize treatment based on actual disease, rather than population-based disease risk. Plaque-IQ equips physicians with critical information regarding the type and amount arterial plaque that can lead to heart attack and stroke. Elucid is also pursuing an indication for FFR-CT, derived from its plaque algorithm, resulting in concordance between plaque and FFR-CT. Elucid’s FFR-CT helps physicians identify coronary blockages and the extent of a patient’s ischemia non-invasively.

References
¹ FFR-CT is under FDA review
² World Health Organization (WHO), Cardiovascular diseases (CVDs). 2017 23, April 2020. Available from: https://www.who.int/en/news-room/fact-sheets/detail/cardiovascular-diseases-(cvds)
³ Ashraf, M. Cardiovascular R&D, M&A and Venture Funding in H2 2024. Dec 12, 2024 https://dealforma.com/cardiovascular-rd-ma-and-venture-funding-in-h2-2024/
⁴ Mueller, A. S., Leipsic, J, et. al. Limitations of Risk- and Symptom-Based Screening in Predicting First Myocardial Infarction. JACC: Advances, vol 4, number 12, part 2, 1 December 2025. https://www.jacc.org/doi/10.1016/j.jacadv.2025.102361
⁵ Virmani, R, et. al. Lessons From Sudden Coronary Death: A Comprehensive Morphological Classification Scheme for Atherosclerotic Lesions. Arteriosclerosis, Thrombosis, and Vascular Biology, vol. 20, no. 5, May 2000. Available from https://doi.org/10.1161/01.ATV.20.5.1262