Method for Rapid Non-Invasive Assessment of Coronary Stenosis

冠状动脉狭窄的快速无创评估方法

• 批准号: 10384509
• 负责人: Josh Nickols
• 金额: $ 22.97万
• 依托单位: VCARDIO INC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-10 至 2023-08-09
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10384509
• 关键词: 3-Dimensional; Arteries; Assessment tool; Blood; Blood flow; Cardiac Catheterization Procedures; Catheterization; Characteristics; Chest Pain; Clinical; Computer Models; Computer software; Consumption; Coronary; Coronary Angiography; Coronary Arteriosclerosis; Coronary Stenosis; Coronary artery; Cost Savings; Derivation procedure; Development; Dimensions; Disadvantaged; Eye; Goals; Gold; Guidelines; Intervention; Ischemia; Lesion; Liquid substance; Machine Learning; Measurement; Measures; Medical; Methods; Modeling; Myocardium; Patients; Pharmaceutical Preparations; Phase; Physics; Procedures; Radiation; Radiation exposure; Retrospective Studies; Running; Sensitivity and Specificity; Severities; Stenosis; Stents; Suggestion; Symptoms; Techniques; Technology; Testing; Time; Validation; base; cohort; computing resources; coronary lesion; interest; laboratory equipment; machine learning algorithm; machine learning model; novel; patient population; pressure; procedure cost; prototype; rapid technique; reconstruction; residence; routine practice; software development; virtual

vCardio, Inc Method for Rapid Non-Invasive Assessment of Coronary Stenosis Project Summary We have developed a non-invasive technique for quantifying the severity of stenosis (blockage) in coronary arteries. One million invasive coronary angiography (ICA) procedures are performed every year in patients who present with chest pain or are known to have stable coronary artery disease (CAD). The goal of the procedure is to determine if there is any significant stenosis that limits blood flow to the heart muscle in the coronary arteries. Almost half of ICAs culminate in stent placement in coronary arteries in order to relieve the blockage of blood flow. The cardiologist performing the procedure in the catheterization lab determines the significance of the stenosis by one of two methods: either by visually estimating the degree of stenosis (‘eyeballing’ the stenosis), which is the routine practice and is done in the majority of patients, or by invasively measuring fractional flow reserve (pressure-wire FFR), which is the Gold Standard test. However, pressure- wire FFR is only performed in 10-20% of patients because it is invasive, expensive, and time- consuming, and requires more radiation and contrast exposure. The proposed technology provides an accurate, highly sensitive and specific, non-invasive method to assess the significance of coronary stenosis through coronary angiography without pressure-wire FFR measurement. When performed in real-time, under 2 minutes, this allows the cardiologist to make an informed decision regarding stent placement. Such a method would deliver the benefits of pressure-wire FFR measurement in terms of cost savings and improvement in patient symptoms, while avoiding disadvantages such as extra cost for the procedure and time burden. It performs favorably compared to competing technology in terms of accuracy but is superior to competition with regards to the time required to run the software. This allows us to provide a truly real-time solution for quantification of coronary stenosis. Our approach uses reduced order modeling methods to model coronary blood flow across stenotic coronary lesions and assess the degree of stenosis severity by incorporating residence time of blood flow through the stenotic segments. The major advantage of this approach over the competing solutions is its potential to deliver a real-time virtual solution within seconds. Once implemented, the solution would merge seamlessly with the current catheterization lab equipment and provide a real-time, objective tool for assessment of coronary lesions by the treating cardiologists. The objective is to scale the study from an initial successful 54 patient study up to 500 patients (400 patients in derivation cohort and 100 patients in validation cohort) by conducting a retrospective study in patients with known CAD who have undergone coronary angiography and pressure-wire FFR measurement for clinical indications.

Vcardio，Inc 快速无创评估冠状动脉狭窄的方法 项目摘要 我们开发了一种非侵入性技术来量化狭窄的严重程度（阻塞） 在冠状动脉中。进行了100万个侵入性冠状动脉造影（ICA）程序 每年出现胸痛或已知患有冠状动脉稳定的患者 疾病（CAD）。该程序的目的是确定是否存在任何明显的狭窄 限制流向冠状动脉中心肌的血液流动。 ICA的几乎一半在 在冠状动脉中放置支架，以减轻血流的阻塞。心脏病专家 在导管插入实验室中执行该过程确定狭窄的重要性 两种方法之一：通过视觉估计狭窄程度（“刻薄”狭窄）， 这是常规练习，在大多数患者中或通过侵入性测量 分数流储备（压力线FFR），这是金标准测试。但是，压力 - FFR仅在10-20％的患者中进行，因为它具有侵入性，昂贵且时间 - 消耗，需要更多的辐射和对比度暴露。 提出的技术提供了准确，高度敏感和特定的，无创的 通过冠状动脉造影评估冠状动脉狭窄的意义的方法 压力线FFR测量。实时执行，不到2分钟，这允许 心脏病专家就支架放置做出明智的决定。这样的方法会 在节省成本和改善方面，提供压力线FFR测量的好处 在患者症状中，避免灾难，例如手术和时间的额外费用 负担。与竞争技术相比，它经常性能在准确性方面与竞争技术相比 在运行软件所需的时间方面，优于竞争。这使我们能够 为定量冠状动脉狭窄提供了真正的实时解决方案。 我们的方法使用降低的订单建模方法来对冠状动脉血流进行建模 狭窄的冠状动脉病变和评估狭窄的严重程度通过纳入居住 血液流过狭窄段的时间。这种方法的主要优势比 竞争解决方案是其在几秒钟内提供实时虚拟解决方案的潜力。一次 实施，该解决方案将与当前导管插入式实验室设备无缝合并 并提供一种实时，客观的工具，用于评估冠状动脉病变 心脏病学家。 目的是将研究从最初成功的54例患者研究中扩展到最多500名患者 （衍生队列中的400名患者，验证队列中的100名患者）通过进行A 对患有冠状动脉造影术的已知CAD患者进行的回顾性研究和 临床适应症的压力线FFR测量。