TC-99M GLUCARATE FOR CHEST PAIN TRIAGE IN EMERGENCY ROOM

目前，每年约有600万名患者进入急诊科，抱怨胸痛。大约有500,000名患者根据ECO立即被诊断为急性心肌梗死(MI)，另有500,000名患者根据心肌酶测试最终被诊断为急性心肌梗死。大约有150万人最终被诊断为不稳定心绞痛，并接受心脏治疗和监测。不幸的是，在这350万名患者中，约有3.5万人因错过急性心肌梗死诊断而被送回家，其中6000人在48小时内死亡。此外，在这350万名患者中，有210万人是在经过广泛的评估和住院后被诊断出来的。国家统计数据表明，这些模棱两可的心肌梗死患者每年约有40亿美元的不必要医疗费用。在急性心肌梗塞患者的治疗中，时间是一个关键因素。第一阶段研究的目的是评估Tc-99m葡萄糖酸盐的安全性、药代动力学和辐射剂量学，第二阶段研究的目的是确定该试剂在急诊科的有用性，以便准确分诊急性心肌梗塞患者的非心源性胸痛。拟议的商业应用：TC-99M葡萄糖酸盐可用于识别急性心肌梗死患者。在急诊室建立这样的程序应该为胸痛患者提供快速的入选和排除，并应该节省稀缺的医疗资源。

Currently, approximately 6.0 million patients enter emergency departments each year complaining of chest pain. Approximately, 500,000 patients are immediately dosed as having acute myocardial infarction (MI) based on an ECO, and an additional 500,000 are ultimately diagnosed as having acute MI based on tests based on cardiac enzymes. Approximately l.5 million are ultimately diagnosed with unstable angina and undergo cardiac treatment and monitoring. Unfortunately, approximately 35,000 of these 3.5 million patients are sent home with a missed acute MI diagnosis, and 6,000 of these MI patients die within 48 hours. In addition, 2.1 million of these 3.5 million patients are diagnosed after extensive evaluation and hospital stays. National statistics indicate that approximately $4.0 billion of unnecessary medical costs are incurred annually on these equivocal MI patients. Time is a critical factor in the treatment of acute MI patients. The purpose of the Phase I research is to evaluate the safety, pharmacokinetics, and radiation dosimetry of Tc-99m glucarate and that of Phase ll is to establish the usefulness of this reagent in the emergency department to enable accurate triage of patients with acute MI form chest pain of non- cardiac origin. PROPOSED COMMERCIAL APPLICATION: Tc-99m glucarate can be used to identify acute myocardial infarction patients. The establishment of such a procedure in emergency room should provide a fast rule-in and rule-out of patients with chest-pain and should conserve scarce healthcare resources.