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.

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.