Embracing the future: James Min left academia to push for a paradigm shift in preventive cardiology

From CCTA research to real-world impact

Min’s journey toward a broader impact began in 2013 with the launch of the Heart Health program at Cornell. This initiative sought to translate research findings into real-world prevention strategies for both symptomatic and asymptomatic patients. The program’s success was striking. Over nearly a decade, the approach prevented myocardial infarctions among its participants.

However, Min recognized a major challenge: The lack of scalability of this model was limited.

"We took sort of a page out of the playbook of screening mammography, that if we understood somebody's disease at the personalized level, using a noninvasive safe image that could effectively guide improved diagnosis, risk stratification, and most importantly, therapeutic guidance, that we could track that disease across time. With that success, we started to ask ourselves, 'Well, that's great, but it'll never sort of go past the Cornell walls. The only way we're going to be able to do this very manual thing is to automate the whole thing and then to try to deliver it at scale so that all medical centers could have access to that capability.' And that's why we started Cleerly," Min explained.

He said an imager can measure and calculate the 3D volumes of the different types of plaques to determine a patient's risk of heart attacks much more precisely than looking at calcified plaques. But, it is very time consuming. Soft plaque detection and analysis from CCTA can also detect patients with coronary disease that have a zero calcium score, but it is rarely done and it is not recommended in the current guidelines unless there is suspicion that plaque might be causing chest pain and appear to have symptomatic disease.

"I prided myself on being a pretty good reader, and then what I realized is that when a computer can figure out the mathematical quantity within a pixel, that can be much, much more accurate than my eyeball can. So I think it does address a very significant problem: it identifies the different types of disease that are there, which it turns out is the most important thing that not only is the amount of disease that you have, but if you have these very high-risk, low-density plaques that really prognosticate the risk based on all of the trials we've seen today," Min explained.

CCTA may play a key role in the future of preventive cardiology

Min and his team at Cleerly are now conducting a large-scale randomized controlled trial called Transform. The study, involving 7,500 patients across 100 sites, aims to prove that personalized cardiovascular evaluation and treatment lead to better outcomes than conventional population-based approaches.

One of the biggest issues in cardiology is that doctors look at surrogate measures for coronary disease, rather that looking at it directly, like you can in a CT scan. Older CCTA technology required high radiation doses, but technology advances have brought CCTA exams down to doses of 1 miliSievert (mSv) or less. Image quality has also increased greatly due to technology advances, including AI-based image reconstruction algorithms. Min said he feels CCTA has come to a point where it could be used the same way as a mammogram, colonoscopy or low-dose CT lung cancer screenings, where you can directly image the disease and get actionable information for prevention years before the disease progresses and becomes symptomatic.

"If you can track your plaque quantitatively and accurately, then you fulfill a number of things that we just didn't have before. There's this concept of residual risk. People talk about putting somebody on a statin and you'll get a 20% relative risk reduction. Well, that means 80% of the people you've put on a statin, you've lowered the cholesterol, but they're still having risk and you don't know who they are. So if you can watch disease progress and it stabilizes or remains unstable, then I think it's a much more powerful way to guide who needs more intensive therapy, more intensive lifestyle modifications," Min said.

He said CCTA could be the key to detaining which patients would benefit from colchicine or the newer, expensive cholesterol lowering agents.

Calcium scoring exams have been popular over the past decade to determine coronary disease risk, but Min said newer research has shown calcium is not as useful as clinicians once believed. He said calcium shows stabilized disease, not vulnerable plaques that can cause a heart attack. When patients are put on statins, the drugs also cause calcification over time, which he said shows the drugs are working, but not the residual risk from soft plaques.

"I think we're entering into an era where we're not only armed with better identification tools, more precision tools to really personalize somebody's heart evaluation, but we've got a huge heavy toolbox of medications and lifestyle modifications that we can use to really prevent people from getting worse before they start to have their events," Min explained.

However, Min realizes changes in medicine takes well powered trial data. For this reason, Cleerly started the TRANFORM trial in 2024. This large-scale, randomized controlled trial will include 7,500 patients to ensure statistical power. The trial, headed by Deepak Bhatt, MD, enrolled its 1,000th patient in November 2024.

"This is a huge effort amongst a hundred sites and investigators, scientists and patients. Our goal here is to prove to the world that this approach of personalized cardiovascular evaluation and treatment is superior to the more population-based approaches that we've been using in the past," Min said.

He said this new trial will either prove or disprove the idea that CCTA can be used as an effective coronary prevention tool.

Find out more about the trial in this video interview with Bhatt - New cardiac prevention paradigm explored in TRANSFORM trial using AI and CCTA

Scaling innovation through AI and policy changes

Cleerly’s technology has already begun to reshape clinical practice. The American Medical Association (AMA) recently approved a Category 1 CPT code for advanced plaque analysis, paving the way for broader insurance reimbursement. Additionally, Cleerly recently introduced an AI-enabled tool called Cleerly Ischemia, which assesses blood flow perturbations, further refining risk assessment and treatment decisions.

Min added that CCTA in 2025 has uniform national coverage and reimbursement for advanced plaque analysis in the symptomatic population. This coverage determination was based on clinical trials showing the benefits of this technology.