New AI-Powered Tech Can Predict Cardiac Events a Decade in Advance

Caristo Diagnostics Limited is sharing promising results of a landmark clinical study that support the ability of its CaRi-Heart AI technology to quantify coronary artery inflammation and accurately predict cardiac events.

The landmark study, “Inflammatory risk and cardiovascular events in patients without obstructive coronary artery disease: the ORFAN multicentre, longitudinal cohort study,” analyzed results from the first 40,000 patients enrolled in the “ORFAN” registry, the world’s largest trial evaluating coronary computed tomography angiography (CCTA) imaging biomarkers in predicting long-term cardiovascular outcomes. The study was published in The Lancet.

“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 Caristo Chief Medical Officer Keith Channon, M.D., professor of Cardiovascular Medicine at the University of Oxford 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.”

• Among patients undergoing CCTA, more than 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 (MACE)
• 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 decision in 45% of the patients. Most changes were due to clinicians’ decision to target the previously undetected coronary inflammation.

“This study, which represents one of the largest studies in the field of CCTA, has important implications for the field of preventive cardiology. I am excited about the potential of the FAI-Score biomarker, which has promising prognostic value beyond existing CT-based methods such as plaque, calcium scoring, and CAD-RADS based interpretation,” stated Ron Blankstein, M.D., 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.  

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.

Caristo claims its patented CaRi-Heart technology marks a scientific breakthrough that is radically transforming the traditional approach to heart disease prediction, prevention and management. The 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. Prior to this publication by The Lancet, earlier validation results showing CaRi-Heart technology’s ability to aid the prediction of heart attacks were published in other medical journals including the Lancet, JACC, European Heart Journal, and Cardiovascular Research.

The CaRi-Heart technology is in clinical use in the U.K., European Union, and Australia.

Caristo Diagnostics is a global developer of cardiac and vascular disease diagnostics and risk prediction solutions. Founded in 2018 as a spin-out company from the University of Oxford Caristo has developed a portfolio of imaging-based and AI-assisted platforms that can be applied to help predict and diagnose heart attack, stroke, and diabetes. Caristo has been recognized by Newsweek as one of the best digital health companies, and highlighted by Nature as one of the most exciting science-based companies to have  emerged from academic labs.