Comprehensive Assessment of Retinal Vasculature (CARV)

视网膜血管系统综合评估（CARV）

基本信息

批准号：
9146953
负责人：
Vinayak S Joshi
金额：
$ 57.02万
依托单位：
VISIONQUEST BIOMEDICAL, LLC
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-03-01 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9146953
关键词：
Adoption Age Age-Years Algorithms Arteries Cardiovascular Diseases Cardiovascular system Classification Clinic Clinical Trials Copper Data Databases Detection Devices Diabetic Retinopathy Diagnostic Diagnostic Procedure Disease Embolism Environment Event Health Heart failure Hemorrhage Hypertensive Retinopathy Image Incidence Individual Institutes Intention Lesion Location Manuals Marketing Measurement Medical Methods Microaneurysm Monitor Myocardial Infarction Optometrist Patients Performance Persons Pharmacy facility Phase Population Prevalence Primary Health Care Process Prospective Studies Reader Reading Real-Time Systems Research Research Personnel Retina Retinal Risk Risk Assessment Risk Factors Rural Sampling Silver Singapore Site Smoking Software Tools Specialist Staging System Telemedicine Testing Time Training Validation Veins Vision Weight base cardiovascular disorder risk commercialization cost experience improved innovation insight retina blood vessel structure screening tool vascular abnormality

项目摘要

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.

描述（由适用提供）：在美国，有720,000年的心脏病发作，其中515,000是心脏病发作。心血管疾病（CVD）的危险因素被认为是明确的，但并未确定所有处于危险的人。因此，有必要检测其他为CVD提供更多近期风险评估的因素。视网膜中发现的危险因素的早期表现可以检测到即将发生的心血管事件的威胁，并监测这些前体提供了对CVD风险的早期见解。因此，我们开发了“视网膜脉管系统的全面评估”（CARV），这是一种用于检测视网膜异常和评估相关CVD风险的完全自动化筛查装置。在第一阶段，Vision Quest Biomedical的研究团队证明了CARV Second Reader系统提供客观测量并检测潜在的血管异常以帮助视网膜读取器的可行性，从而在减少的阅读时间中增加了疾病的检测。在第二阶段，第二读取器系统将演变为一个全自动的第一读取器系统，该系统量化了基于视网膜异常的CVD风险。我们将通过两个具体目标来实现这一目标。在第一个目标中，我们将添加用于检测视网膜异常和病变的其他方法。然后，我们将开发一个分类器，以自动为每个案例carV过程分配低，中度或重度的CVD风险。在第二个目标中，我们将结合这些软件工具，以生成近乎实时的系统，以自动检测高血压视网膜病的迹象，并根据结果分配CVD风险等级。在第二阶段结束时，我们将演示经过验证的CARV第一读者和第二读者系统。 FDA可能会为CARV第二读者提供I类设备，我们希望在一年内清算。预期的用途将是对远程医疗环境中读者的帮助。在CARV Second Reader用作谓词设备的情况下，CARV第一读取器系统可以作为510K设备作为FDA提交，因为临床试验成功完成。