AI Nears ‘Gold Standard’ in Heart Disease Imaging, Paving Way for New Care

VIENNA, AUSTRIA – March 20, 2026 – A significant leap forward in cardiovascular diagnostics was unveiled this week, as new research demonstrates an artificial intelligence platform can analyze heart disease with an accuracy that rivals invasive, “gold-standard” procedures. The findings, presented at the European Congress of Radiology (ECR 2026), signal a potential paradigm shift in how doctors identify and manage the root cause of heart attacks.

At the heart of the announcement is Cleerly, a medical technology company, and its multicenter INVICTUS registry. The study directly compared the company’s AI-enabled quantitative computed tomography (AI-QCT) analysis with intravascular ultrasound (IVUS), a highly-respected but invasive technique. The results, simultaneously published in the peer-reviewed journal European Radiology, showed a remarkably high level of agreement, suggesting that a simple, non-invasive CT scan, when analyzed by advanced AI, can provide a wealth of information previously only attainable by threading a catheter into a patient's arteries.

“Every time we reach a scientific milestone that makes accurate plaque characterization more accessible and less invasive, we get closer to our goal of eliminating heart attacks,” said James K. Min, founder and CEO of Cleerly, in a statement. The results from the INVICTUS registry may prove to be a pivotal moment on that journey.

A New Benchmark for Non-Invasive Imaging

For decades, cardiologists have relied on invasive procedures to get a definitive look inside the coronary arteries. Intravascular ultrasound, or IVUS, involves guiding a miniature ultrasound probe on the end of a catheter directly to the heart. It provides a detailed, cross-sectional view of the artery wall, allowing physicians to precisely measure plaque buildup. Due to its accuracy, IVUS is considered a “gold standard” for assessing plaque burden and guiding interventions like stent placement. However, it is an invasive procedure reserved for specific situations, carrying inherent risks and costs.

The INVICTUS registry, which enrolled patients across 17 centers in Japan, was designed to challenge this paradigm. Researchers investigated whether Cleerly’s AI-QCT could provide the same level of detail as IVUS from a standard coronary CT angiography (CCTA) scan. The results were striking. AI-QCT demonstrated a strong correlation with IVUS across a host of critical measurements, showing a mean difference of just -0.09% in measuring arterial plaque, with 94.4% of all measurements falling within the limits of agreement.

Key metrics used to measure the severity of artery disease showed powerful associations between the two methods, including measurements for vessel volume (r=0.899), the open channel for blood flow, or lumen volume (r=0.943), and most importantly, the total plaque volume itself (r=0.833). The AI also achieved 99.1% agreement in classifying the predominant type of plaque at the point of greatest narrowing. “IVUS has long been the gold standard in invasive plaque imaging, and the findings from INVICTUS represent an important advance in establishing the clinical validity of noninvasive plaque quantification,” Min noted.

Beyond Blockages: The Science of Plaque Characterization

The significance of the INVICTUS findings extends beyond simply matching an older technology. It reinforces a critical evolution in cardiology: the understanding that heart attack risk is not just about how much an artery is narrowed, but about the total amount and type of plaque buildup within it. Traditional methods often focused on identifying significant blockages, or stenosis, that restrict blood flow. However, a large proportion of heart attacks are caused by the rupture of less-constrictive, but more volatile, plaques.

This is where Cleerly's technology finds its niche. Instead of just looking for blockages, its AI-driven platform performs a comprehensive phenotyping of the disease. It analyzes the entire coronary artery tree from a CCTA scan, meticulously identifying, characterizing, and quantifying all forms of atherosclerotic plaque. This includes stable, calcified plaque as well as the more dangerous soft, non-calcified and low-attenuation plaques, which are often implicated in acute cardiac events.

This anatomical, plaque-focused approach provides a different, yet complementary, view compared to functional tests that measure blood flow restriction (ischemia). By focusing on the underlying disease burden itself, the technology aims to give clinicians a more complete picture of a patient's true risk, enabling a shift from reactive treatment of symptoms to proactive, preventative care based on an individual's specific disease profile.

Paving the Way for a New Standard of Care

With strong clinical validation in hand, the path is clearing for AI-powered plaque analysis to become a more integrated part of routine cardiovascular care. The primary benefit is the ability to offer patients a safer, more accessible diagnostic pathway. A non-invasive CCTA scan can be performed in minutes and, with AI analysis, can yield a comprehensive risk profile without the need for a hospital stay or the risks associated with an invasive procedure.

Market adoption, however, depends on more than just technology. It requires regulatory clearance and, critically, a clear pathway for reimbursement. Cleerly has been strategic on this front, having already secured FDA clearance for its solutions. More importantly, the company championed the creation of new Category III CPT codes (0757T, 0758T, 0759T), which became effective in 2023, allowing providers to bill for AI-driven quantitative plaque analysis. This has been followed by further success in obtaining coverage from major health plans, dismantling one of the most significant barriers to the widespread adoption of new medical technologies.

This combination of clinical validation and commercial-readiness positions the technology to move from specialized research centers into community hospitals and cardiology clinics, potentially changing the diagnostic journey for millions of patients with suspected heart disease.

The Road Ahead: From Diagnosis to Outcome

Validating a diagnostic tool against a gold standard is a critical milestone, but the ultimate goal in medicine is to improve patient outcomes. The next frontier for Cleerly and the field of AI in cardiology is to demonstrate conclusively that using this detailed plaque information to guide treatment decisions leads to fewer heart attacks, lower healthcare costs, and longer lives.

Large-scale clinical trials are already underway to answer this question. The recently announced TRANSFORM trial, for example, is designed to prove that a personalized care strategy based on Cleerly’s analysis is superior to the current standard of care for the primary prevention of cardiovascular events. Other studies, like CONSERVE, have already suggested that an AI-guided approach can significantly reduce the rate of unnecessary invasive angiograms and lower overall costs without compromising patient safety.

As this body of evidence grows, the vision of a new standard of care for heart disease comes into sharper focus. It is a future where a patient’s risk is no longer estimated with broad statistical models, but precisely defined by the biology of their own arteries. The findings from the INVICTUS registry are a crucial and convincing piece of that puzzle, moving the field one step closer to transforming heart disease from an acute catastrophe into a manageable chronic condition.