Biograph Completes First U.S. Study on AI Coronary Inflammation Detection

Study Overview

Biograph announced the completion of its first U.S. study using Caristo Diagnostics' CaRi-Heart technology to evaluate AI-powered coronary inflammation detection in asymptomatic, low-risk individuals. The study was available to clinically eligible Biograph Black tier members and combined Biograph diagnostics, including high-resolution coronary computed tomography angiography imaging and cardiometabolic profiling, with Caristo's CaRi-Heart and CaRi-Plaque technologies.

Key Findings

The study found that 42.9% of participants had elevated inflammation, while 17.9% had very high inflammation in at least one major heart artery. About 47% of participants with no detectable coronary plaque had elevated coronary perivascular inflammation. Routine bloodwork and clinical tools, including cholesterol markers (ApoB, non-HDL-C), blood sugar (HbA1c), systemic inflammation (hs-CRP), and the AHA PREVENT-ASCVD calculator, showed no correlation with coronary inflammation and failed to identify patients with inflamed arteries.

Expert Comment

Michael Doney, MD, MPH, MS, Executive Medical Director of Biograph, said coronary heart disease may be a late consequence of an active inflammatory process in the vessel wall. He said more than 42% of asymptomatic, conventionally low-risk adults had elevated coronary inflammation, and many with the highest inflammatory levels had normal coronary anatomy on CT. He added that no routine blood biomarker, lipid metric, or clinical risk score could identify those individuals, suggesting an upstream phase of disease and a window for proactive intervention. More research is needed to validate the finding and establish prognostic value and benefit of care directed at coronary perivascular inflammation.

Regulatory Status

CaRi-Heart has received U.S. Food and Drug Administration De Novo marketing authorization and is described as the first and only solution to quantify coronary inflammation from routine coronary CT angiography. CaRi-Plaque has received U.S. FDA clearance for AI-assisted coronary plaque and stenosis analysis. The clinical study manuscript is available as a published preprint.

Sources: biograph.com