Cleerly has introduced an innovative Coronary Artery Disease (CAD) staging system, utilising noninvasive imaging technology to analyse crucial aspects of coronary atherosclerosis, stenosis, and ischaemia.
This system aims to offer physicians a more precise and personalised risk assessment for patients susceptible to major adverse cardiovascular events (MACE), such as heart attacks, prior to their occurrence.
The Cleerly CAD staging system will undergo further validation through the groundbreaking TRANSFORM randomised controlled trial, which will recruit asymptomatic individuals with diabetes, pre-diabetes, or metabolic syndrome.
Currently, the assessment of future MACE in asymptomatic patients relies primarily on risk factors rather than the direct diagnosis and staging of CAD, which is the primary cause of most heart attacks. While risk factors provide reasonable prognostic value across populations, they are indirect indicators of CAD, and their correlation with CAD severity and individual CAD risk is often uncertain and unreliable.
The CAD Staging System will be available to physicians and patients, and offer a basis for implementing tailored preventive CAD treatment with therapy goals based on individual risk.
The U.S. Food and Drug Administration (FDA) has granted breakthrough designation for Cleerly's coronary artery disease (CAD) staging system.
