Biograph, the world’s most advanced preventive health and diagnostics clinic, today announced the completion of its first U.S. study using Caristo Diagnostics’ CaRi-Heart® technology evaluating AI-powered coronary inflammation detection in asymptomatic, low-risk individuals. The research revealed that coronary inflammation is widespread among asymptomatic adults without known heart disease – and is undetected by standard blood tests and other traditional cardiovascular risk factors.
The study, available to clinically eligible Biograph Black tier members, combined Biograph’s advanced diagnostics – including high-resolution coronary computed tomography angiography (CCTA) imaging and cardiometabolic profiling – with Caristo’s CaRi-Heart and CaRi-Plaque® technologies*. This collaborative methodology enabled researchers to assess the prevalence of coronary inflammation using the AI-enabled CaRi-Heart technology to determine cardiovascular risk in individuals who may otherwise appear low risk through traditional screening.
The study found that coronary inflammation is common (42.9%) in asymptomatic, low-risk adults and frequently occurs without any plaque buildup or blockage. Specifically, 42.9% of participants exhibited elevated inflammation with 17.9% of participants exhibiting very high inflammation in at least one major heart artery. The results also suggest a potential limitation in standard assessment: About 47% of participants with no detectable coronary plaque exhibited elevated coronary perivascular inflammation. By evaluating coronary inflammation alongside traditional imaging assessment of plaque burden and stenosis, we get a more complete picture of cardiovascular risk..
Importantly, routine bloodwork and clinical tools – including cholesterol markers (ApoB, non-HDL-C), blood sugar (HbA1c), systemic inflammation (hs-CRP), and a widely used cardiovascular risk calculator (AHA PREVENT-ASCVD) – showed no correlation with the presence of coronary inflammation and failed to identify which patients had inflamed arteries. These results reinforce Biograph’s core philosophy: standalone bloodwork and isolated metrics do not tell the full story. By directly analyzing the biology of the tissue surrounding the coronary arteries, this non-invasive AI technology uncovers potential cardiovascular risk years before the onset of irreversible heart disease.
For Biograph, the completion of this study reflects its broader mission to advance proactive, personalized healthcare through comprehensive diagnostics, clinical interpretation, and earlier insight into long-term health risks. To review the clinical study manuscript, readers can access the published preprint here.
*CaRi-Heart® has received U.S. Food and Drug Administration (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 received U.S. FDA clearance for AI-assisted coronary plaque and stenosis analysis, complementing CaRi-Heart by evaluating quantitative plaque.