A New Breakthrough in Heart Health Screening
Cardiovascular disease is the world's leading cause of death, with roughly 85% of those deaths caused by heart attacks and strokes. However, standard risk tools often miss patients at elevated risk—including those with no coronary calcium, no standard modifiable risk factors, or no history of atrial fibrillation.
New data presented at the European Society of Cardiology (ESC) Congress 2026 shows that an independent University of Oxford-led research team used Caristo Diagnostics' FAI-Score™ biomarker technology to successfully assess coronary inflammation from non-contrast cardiac CT—a scan that takes less time, doesn't require dye, and is typically less expensive than contrast CT. Even in patients with a zero-calcium score, those with elevated FAI-Score™ had a significantly higher risk of cardiovascular mortality.
Going Beyond Traditional Risk Factors
A separate analysis found that coronary inflammation, measured by FAI-Score, predicted cardiovascular death even in patients with none of the standard modifiable risk factors (SMuRFs)—diabetes, hypertension, high cholesterol, smoking, and obesity. The predictive value was strongest in this group, underscoring the potential limitations of traditional risk-factor-based assessment alone.
"Nearly 50% of first-time heart attacks occur in people classified as 'low-risk' by traditional cardiovascular risk assessments, underscoring the need for new ways to identify vulnerable patients earlier," said Steve Deitsch, CEO of Caristo Diagnostics.
Predicting Stroke: A New Tool Independent of Atrial Fibrillation
In a decade-long ORFAN-MAESTRIA study of more than 81,000 patients, researchers found that Caristo's AI technology identified signs of left atrial myopathy on routine cardiac CT that predicted future stroke risk. Patients identified as high-risk had a 17-fold higher likelihood of cardioembolic stroke than those identified as low-risk, outperforming today's standard clinical risk tool. Importantly, the algorithm flagged this risk independently of atrial fibrillation, meaning it can catch danger in patients who show no warning signs on a standard heart rhythm test.
AI 'Virtual Biopsy' Predicts Long-Term Cardiac Mortality
In a separate investigator-led ORFAN analysis, researchers developed an AI signature designed to create a "virtual biopsy" of cytokine-driven inflammation in the artery wall across more than 80,000 patients in the UK and US. The signature predicted long-term cardiac mortality in the cohorts, along with an elevated risk of heart failure and kidney disease among patients with the highest inflammation signal. This analysis remains investigational and is not currently available as a commercial product.
From Research to Clinical Practice: FDA-Authorized Technology
Caristo's CaRi-Heart® technology has received U.S. FDA De Novo marketing authorization and is the first and only solution to quantify coronary inflammation from routine coronary CT angiography (CCTA). CaRi-Plaque® has also received FDA 510(k) clearance to analyze cardiac CT images for coronary plaques and luminal stenoses. Both products are commercially available in the U.S., Europe, the UK, Switzerland, and Australia.
"By applying the same biological framework to different pieces of the cardiovascular puzzle, we can help clinicians detect high-risk patients sooner and intervene earlier," said Professor Charalambos Antoniades, British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford and principal investigator of the ORFAN-MAESTRIA study.
"Research like this shows the value of investing in science that can move from discovery towards practical tools for patient care," added Prof. James Leiper, Director of Research at the British Heart Foundation.
These findings suggest that in the future, cardiac CT screening may not require contrast dye to comprehensively assess cardiovascular risk. For those concerned about heart health, regular cardiac imaging combined with AI-assisted analysis may help detect potential risks earlier. The Xiaoshu Health App can sync with Apple Health to track relevant metrics and help you stay on top of your cardiovascular health data.