Boston — Elucid said it has enrolled the first patient in AI-PREDICT, a retrospective international multicenter study designed to establish a lesion-focused approach to cardiovascular risk stratification.
The study will use AI-powered coronary CT angiography analysis to evaluate lesions and advance Elucid’s CCTA 3.0 vision for personalized treatment of coronary artery disease.
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 in Milan. The sites are led by principal investigators Carlo N. De Cecco, MD, PhD; Akos Varga-Szemes, MD, PhD, MBA; and Gianluca Pontone, MD, PhD.
AI-PREDICT is expected to enroll about 1,000 subjects, including patients who experienced a myocardial infarction within 36 months of a baseline CCTA and clinically matched controls who did not experience an event. The study will generate 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-CT 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,” said Dr. Pontone.
Heart disease remains the leading cause of death globally. Elucid said many heart attacks arise from plaques that progress silently in the moderate stenosis range and do not cause symptoms before triggering an event. The AI-PREDICT study is designed to better identify and stratify those lesions in advance.
The study is led by cardiovascular scientists and imaging specialists. Jagat Narula, MD, PhD, president of the World Heart Federation, is serving as principal investigator. De Cecco, professor of Radiology and Biomedical Informatics and director of the Cardiothoracic Imaging Division at Emory University School of Medicine, is serving as co-principal investigator.
The study’s Steering Committee is co-chaired by Amir Ahmadi, MD, clinical associate professor of medicine in cardiology at the Icahn School of Medicine at Mount Sinai and lead scientific advisor at Elucid, and Michael Hadley, MD, system director of Advanced Cardiac Imaging at Northwell Health.
“AI-PREDICT represents a fundamental shift in how we think about cardiovascular risk,” said Dr. Narula. “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 said.
Elucid said AI-PREDICT reflects its work to move cardiovascular care toward CCTA 3.0, the company’s vision for personalized, lesion-level care.
