Comprehensive Assessment of Retinal Vasculature (CARV)

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 DESCRIPTION (provided by applicant): In the US, there are 720,000 annual incidences of heart attack, out of which 515,000 are first time heart attacks. Risk factors for cardiovascular disease (CVD) are thought to be well-defined, but they do not identify all at-risk individuals. Therefore, there is a need to detect other factors that provide more near-term risk assessment for CVD. The early manifestations of risk factors found in the retina can detect a threat of an impending cardiovascular event, and monitoring these precursors provides an early insight into risk of CVD. For this reason, we have developed the "Comprehensive Assessment of Retinal Vasculature" (CARV), a fully automated screening device for the detection of retinal abnormalities and assessment of associated CVD risk. In Phase I, the research team at Vision Quest Biomedical demonstrated the feasibility of the CARV second reader system to provide objective measurements and detect potential vascular abnormalities to assist a retinal reader, resulting in increased disease detection at a reduced reading time. In Phase II, the second reader system will evolve into a fully automatic first reader system that quantifies the risk of CVD based on retinal abnormalities. We will accomplish this through two specific aims. In the first aim, we will add additional methods for detecting retinal abnormalities and lesions. We will then develop a classifier to automatically assign a CVD risk of low, moderate, or severe to each case CARV processes. In the second aim, we will combine these software tools to produce a near real-time system to automatically detect signs of hypertensive retinopathy and assign a CVD risk grade based on the results. At the end of Phase II, we will demonstrate a validated CARV first reader and second reader system. CARV second reader will likely be given a Class I device by the FDA, and we expect clearance within a year. The intended use will be that of an aid to readers in a telemedicine environment. With CARV second reader serving as a predicate device, the CARV first reader system can be submitted as a 510k device to the FDA, following the successful completion of a clinical trial.