Caristo study links coronary inflammation to higher death risk
A University of Oxford-led study of 19,110 patients found that Caristo Diagnostics’ CaRi-Heart technology added prognostic information beyond coronary artery calcium, non-calcified plaque and traditional cardiovascular risk factors. The research, published in JAMA Cardiology, found sharply higher cardiovascular death risks among some patients with little or no detectable plaque.
- The study included 19,110 patients and was published in JAMA Cardiology.
- Very high inflammation with a calcium score of zero was linked to a 14.1x higher cardiovascular death risk.
- Very high inflammation without calcified or non-calcified plaque was linked to a 10.4x higher risk.
- FAI-Score reclassified nearly half of later cardiovascular deaths among patients with a calcium score of zero.
- Use of FAI-Score on non-contrast CT scans is investigational.
Inflammation identified risk missed by calcium scoring
According to Caristo Diagnostics, patients with a very high coronary inflammation assessment and a calcium score of zero had a 14.1x higher risk of cardiovascular death. A very high inflammation assessment in patients without calcified or non-calcified plaque was associated with a 10.4x higher risk.
The study also found that 51% of major cardiovascular events and 42% of cardiovascular deaths occurred in patients with a coronary artery calcium score below 100. Among patients with a calcium score of zero who later died from cardiovascular causes, FAI-Score reclassified nearly half as high or very high risk, according to the company.
What CaRi-Heart measures
FAI-Score is the measurement behind CaRi-Heart. Caristo describes it as a validated, proprietary biomarker of coronary inflammation. Its artificial intelligence analyzes the fat surrounding the coronary arteries, known as pericoronary adipose tissue, on a routine coronary CT angiogram, or CCTA.
The system corrects for technical and biological factors so results are standardized across patients and imaging environments. Caristo says CaRi-Heart is the first and only FDA-authorized technology to quantify coronary inflammation. The company also says the technology can identify hidden heart disease and people at risk of heart attack before symptoms appear.
“Unlike calcium and plaque, which reflect the result of atherosclerotic disease, coronary inflammation is the biology driving the disease,” said Professor Charalambos Antoniades, British Heart Foundation Chair of Cardiovascular Medicine at the University of Oxford and senior author of the study. “Our research shows that coronary inflammation is an independent predictor of cardiovascular death, adding vital prognostic information even in the absence of calcified or non-calcified plaque.”
Research expansion could reach routine calcium scans
The research also points to a possible expansion of Caristo’s technology for the millions of asymptomatic people undergoing routine non-contrast scans used for calcium scoring. Applying FAI-Score to non-contrast CT scans remains investigational, according to the company.
Steve Deitsch, CEO of Caristo Diagnostics, said the findings support looking beyond plaque, calcium scores and traditional risk factors when assessing cardiovascular risk. Caristo said the results could help physicians improve clinical management and provide more personalized risk predictions, while the study’s findings establish coronary inflammation as an additional factor in cardiovascular risk assessment.
