Targeted Nanoparticles of Bismuth Organo Complexes for Spectral CT Imaging of Cor

描述（由申请人提供）：急诊科（艾德）就诊的胸痛患者面临临床困境：转移进行紧急冠状动脉血运重建，住院过夜进行心脏遥测和负荷测试，或出院回家进行医学随访。在该提议中，我们假设一种新的血栓特异性光谱计算机断层扫描（多色CT）纳米颗粒（即，NanoK）方法在艾德中直接快速评估冠状动脉疾病可以帮助解决这一临床难题。该项目由Ocean NanoTech与华盛顿大学合作领导，将完成GLP-/GMP就绪1-纤维蛋白NanoK产品候选产品的开发，该产品适用于GLP稳定性和毒性测试，以支持FDA IND。该NanoK平台技术为急性冠状动脉疾病的诊断和治疗提供了独特的优势，可以改善医疗保健结果并降低成本。 公共卫生相关性：急诊科（艾德）患者的胸痛给临床带来了两难选择：转移至急诊冠状动脉血运重建，住院过夜进行心脏遥测和负荷测试，或出院回家进行医疗随访。虽然紧急需要心导管插入术是不言自明的，从一些人的介绍，是否承认或出院的病人与模棱两可的历史和身体的决定往往是有问题的。代替错过关键的心脏诊断，患者被允许进行心肌评估和负荷测试，这在大多数情况下是不方便、昂贵和不必要的。在该提议中，我们假设一种新的血栓特异性光谱计算机断层扫描（多色CT）纳米颗粒（即，NanoK）方法在艾德中直接快速评估冠状动脉疾病可以帮助解决这一临床难题。本项目描述了第1阶段原型概念的证明以及第2阶段临床候选产品的开发、证明和表征。该项目的总体目标，这是由海洋纳米技术与华盛顿大学合作，将完成开发的GLP- /GMP准备1-纤维蛋白NanoK产品候选人适当先进的GLP稳定性和毒性测试，以支持FDA的IND。该NanoK平台技术提供了独特的好处，诊断和治疗急性冠状动脉疾病，可以改善医疗保健结果和降低成本。

DESCRIPTION (provided by applicant): Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project, which is led by Ocean NanoTech in collaboration with Washington University, will complete development of a GLP-/GMP-ready 1- fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs. PUBLIC HEALTH RELEVANCE: Chest pain in patients presenting to the emergency department (ED) present a clinical dilemma: transfer for emergent coronary revascularization, admit overnight for cardiac telemetry and stress testing, or discharge home with medical follow-up. While the emergent need for cardiac catheterization is self evident from the presentation of some individuals, the determination of whether to admit or discharge a patient with an equivocal history and physical is often problematic. In lieu of missing a critical cardiac diagnosis, patients are admitted for myocardial evaluation and stress testing, which is inconvenient, costly and unnecessary in the majority of cases. In this proposal, we hypothesize that a novel thrombus-specific Spectral Computed Tomography (Multicolored CT) nanoparticle (i.e., NanoK) approach for direct rapid assessment of coronary disease in the ED could help resolve this clinical dilemma. This project describes the demonstration of the prototype concept in Phase 1 and the development, demonstration, and characterization of the clinical product candidate in Phase II. The overarching goal of this project, which is led by Ocean NanoTech in collaboration with Washington University, will be to complete development of a GLP- /GMP-ready 1-fibrin NanoK product candidate suitably advanced for GLP stability and toxicity testing to support an FDA IND. This NanoK platform technology offers unique benefits for diagnosis and treatment of acute coronary disease that could improve healthcare outcomes and reduce costs.