New AI tech predicts cardiac events due to coronary inflammation

The Lancet publishes results from landmark study showing inflammation-related cardiac events can be predicted 10 years in advance.

Caristo Diagnostics has announced the results of a clinical study that support the ability of Caristo’s CaRi-Heart AI technology to quantify coronary artery inflammation and accurately predict cardiac events.

Published in The Lancet, the multicenter, longitudinal cohort study, titled Inflammatory risk and cardiovascular events in patients without obstructive coronary artery disease, analyzed results from the first 40,000 patients enrolled in the Oxford Risk Factors And Non Invasive Imaging Study (ORFAN). ORFAN is the world’s largest study evaluating coronary computed tomography angiography (CCTA) imaging biomarkers in predicting long-term cardiovascular outcomes.

Longevity.Technology: Cardiovascular disease (CVD) remains the world’s leading cause of mortality, underscoring the critical need for early detection and risk assessment to mitigate its devastating impact. Obesity is a well-established risk factor for CVD, with increased body fat correlating with a heightened risk of heart disease; however, emerging research from the ORFAN study aims to refine our understanding by demonstrating that not just the quantity, but also the characteristics of adipose tissue, are crucial for assessing CVD risk.

The ORFAN study uses computed tomography (CT) to non-invasively and accurately characterize adipose tissue, focusing on both subcutaneous fat and the fat surrounding the heart and coronary vessels. By integrating CT imaging data with blood biomarkers, the study seeks to predict an individual’s likelihood of experiencing cardiovascular events, such as heart attacks or strokes. Additionally, the researchers aim to determine if these blood biomarkers can forecast the progression of cardiovascular disease. It is a comprehensive approach that highlights the importance of identifying individuals at risk, potentially allowing for earlier and more personalized interventions to prevent CVD.

Caristo’s patented CaRi-Heart technology, which is in clinical use in the UK, European Union and Australia, hopes to radically transform traditional approach to heart disease prediction, prevention and management. The platform’s technology applies advanced AI algorithms to routine coronary computed tomography angiography (CCTA) scans to visualize and quantify coronary inflammation, the otherwise invisible disease mechanism responsible for many fatal heart attacks and strokes.

Key study findings include [1]:

  • Among patients undergoing CCTA, about 80% did not have obstructive coronary artery disease (CAD) at the time of imaging, but twice as many fatal and non-fatal cardiac events occurred in that group.
  • Coronary inflammation, as measured by Caristo’s CaRi-Heart FAI-Score, predicted fatal and non-fatal cardiac events (including heart attack and new heart failure), independently from traditional risk factors, routine clinical CCTA interpretation, calcium scoring and plaque quantification, at least 10 years in advance.
  • Even among the 50% of patients who had no or minimal coronary plaque at the time of the initial CCTA, those with the most abnormal FAI-Score results experienced a 9.5-fold higher risk for cardiac mortality and 5.5-fold higher risk for major adverse cardiac events.
  • Caristo’s AI-Risk model, CaRi-Heart Risk Score, outperformed other scores in routine clinical use for prediction of cardiac mortality, and when presented to clinicians, resulted in changes of management in 45% of the patients. Most changes were due to clinicians’ decision to target the previously undetected coronary inflammation.

“The ORFAN study is an expanding global registry which will include long-term clinical and outcome data for 250,000 patients from around the world, and we are very pleased to publish these initial results,” said Keith Channon, MD, Professor of Cardiovascular Medicine at University of Oxford, Caristo Chief Medical Officer, and co-author of The Lancet publication.

“Coronary inflammation is a crucial piece of the puzzle in predicting heart attack risk. We are excited to discover that CaRi-Heart results performed exceptionally well in predicting patient cardiac events. This tool is well positioned to help clinicians identify high-risk patients with seemingly ‘normal’ CCTA scans.”

Ron Blankstein, MD, Professor of Medicine and Radiology at Harvard Medical School, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and co-author of the publication, applauded The Lancet for publishing results from one of the largest studies in the field of CCTA.

“I am excited about the potential of the FAI-Score biomarker, which was invisible to physician eyes without the CaRi-Heart technology and has promising prognostic value beyond existing CT-based biomarkers such as plaque, calcium score, and CAD-RADS,” he added.

The study underlines the need for a robust risk prediction tool that can identify vulnerable patients with inflamed coronary arteries, particularly in those without obstructive CAD; this approach would transform CCTA from a test used to triage a minority of patients for further intervention into a prevention tool that guides management for all patients undergoing CCTA.

READ MORE: Check out our interview with Frank Cheng, CEO of Caristo Diagnostics

[1] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00596-8/fulltext