Method for Rapid Non-Invasive Assessment of Coronary Stenosis

冠状动脉狭窄的快速无创评估方法

基本信息

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
项目类别：
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

项目摘要

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 公司冠状动脉狭窄的快速无创评估方法项目概要我们开发了一种非侵入性技术来量化狭窄（阻塞）的严重程度在冠状动脉中进行了 100 万次侵入性冠状动脉造影 (ICA) 手术。每年出现胸痛或已知冠状动脉稳定的患者该手术的目的是确定是否存在任何明显的狭窄。限制冠状动脉中流向心肌的血液。几乎一半的 ICA 最终会导致心肌梗死。心脏病专家在冠状动脉中放置支架以缓解血流阻塞。在导管实验室中执行该手术可通过以下方式确定狭窄的严重程度两种方法之一：通过目视估计狭窄程度（“目测”狭窄），这是大多数患者的常规做法，或者通过侵入性测量血流储备分数（压力线 FFR），这是黄金标准测试。线 FFR 仅在 10-20% 的患者中进行，因为它是侵入性的、昂贵的且耗时。消耗，并且需要更多的辐射和对比曝光。所提出的技术提供了准确、高度敏感和特异的、非侵入性的通过冠状动脉造影评估冠状动脉狭窄的意义的方法实时执行压力线 FFR 测量时，可在 2 分钟内完成心脏病专家可以就支架置入做出明智的决定。提供压线 FFR 测量在成本节约和改进方面的优势减少患者症状，同时避免额外的手术费用和时间等缺点与竞争技术相比，它在准确性方面表现良好，但在运行软件所需的时间方面优于竞争对手，这使我们能够为冠状动脉狭窄的量化提供真正实时的解决方案。我们的方法使用降阶建模方法来模拟冠状动脉血流狭窄的冠状动脉病变并通过结合居住地评估狭窄的严重程度与传统方法相比，这种方法的主要优点是血流通过狭窄段的时间。具有竞争力的解决方案是其在几秒钟内提供实时虚拟解决方案的潜力。实施后，该解决方案将与当前的导管实验室设备无缝融合并通过治疗提供实时、客观的工具来评估冠状动脉病变心脏病专家。目标是将研究规模从最初成功的 54 名患者研究扩大到 500 名患者（推导队列中有 400 名患者，验证队列有 100 名患者）对住院接受冠状动脉造影并患有已知 CAD 的患者进行回顾性研究用于临床适应症的压力线 FFR 测量。