Biograph诊所与Caristo Diagnostics公司合作完成了美国首项研究,使用AI驱动的CaRi-Heart®技术在无症状低风险人群中检测冠状动脉炎症。1研究表明,42.9%的无症状低风险成年人存在升高的冠状动脉炎症,其中17.9%在至少一条主要冠状动脉中表现出极高炎症水平。1
研究发现这些炎症往往逃脱传统诊断方法的检测。1具体而言,约47%未检测到冠状动脉斑块的患者出现了升高的冠状动脉血管周围炎症。1传统血液检查指标包括ApoB、非HDL胆固醇、HbA1c和高敏C反应蛋白,以及美国心脏协会的PREVENT-ASCVD风险计算器与冠状动脉炎症均无相关性。1
CaRi-Heart®已获得美国食品药品监督管理局的De Novo营销授权,成为首个且唯一能够量化常规冠状动脉CT血管造影中冠状动脉炎症的解决方案。1CaRi-Plaque®产品已获得美国FDA对冠状动脉斑块和狭窄分析的认可。1
Biograph clinic and Caristo Diagnostics have completed the first U.S. study using AI-powered CaRi-Heart® technology to detect coronary artery inflammation in asymptomatic, low-risk individuals 1. The research found that 42.9% of asymptomatic low-risk adults exhibited elevated coronary artery inflammation, with 17.9% showing extremely high inflammation levels in at least one major coronary artery 1. These inflammatory markers typically go undetected by conventional blood tests and standard cardiovascular risk assessments 1.
The study revealed a significant gap between traditional diagnostic approaches and AI-enabled imaging analysis. Approximately 47% of participants with no detectable coronary plaque still showed elevated pericoronary inflammation 1. Standard blood markers—including ApoB, non-HDL cholesterol, HbA1c, and high-sensitivity C-reactive protein—showed no correlation with coronary artery inflammation, nor did risk calculations from the American Heart Association's PREVENT-ASCVD tool 1.
The CaRi-Heart® technology has received U.S. FDA De Novo marketing authorization as the first and only solution that quantifies coronary artery inflammation in routine coronary CT angiography 1. A related technology, CaRi-Plaque®, has also obtained FDA approval for coronary plaque and stenosis analysis 1.
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