The TRANSFORM clinical trial aims to revolutionize cardiovascular disease prevention by combining coronary CT angiography (CCTA) with an AI-driven algorithm to assess atherosclerotic plaque buildup and predict heart attack risk more accurately than traditional methods. Led by Dr. Deepak L. Bhatt at Mount Sinai, the study will enroll 7,500 asymptomatic patients across the U.S., comparing standard care to an AI-guided plaque staging system developed by Cleerly. High-risk patients will receive aggressive, personalized medical therapy, targeting cholesterol, inflammation, and thrombosis to prevent disease progression. Participants in the AI-driven group will undergo a follow-up CCTA at 24 months to track changes and refine treatment. If successful, TRANSFORM could establish a new model for cardiovascular risk assessment, mirroring cancer staging, and significantly improving patient outcomes. Read the article here.

Dr. Parikh, principal investigator at CVISD, states “this trial will pave the way for screening patients for coronary artery disease before they have a heart attack and not waiting until they have symptoms. This proactive approach will save millions of lives and can eliminate heart disease as the number one leading cause of death.”