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

目前，每年约有600万患者因胸痛进入急诊室。大约有500，000名患者根据ECO立即被诊断为急性心肌梗死（MI），另外500，000名患者根据基于心肌酶的测试最终被诊断为急性MI。大约150万人最终被诊断为不稳定型心绞痛，并接受心脏治疗和监测。不幸的是，这350万患者中约有35，000人因错过急性MI诊断而被送回家，其中6，000人在48小时内死亡。此外，在这350万患者中，有210万是在经过广泛的评估和住院治疗后确诊的。国家统计数据表明，每年约有40亿美元的不必要的医疗费用发生在这些模棱两可的MI患者身上。时间是治疗急性心肌梗死患者的关键因素。I期研究的目的是评价Tc-99 m葡萄糖二酸盐的安全性、药代动力学和辐射剂量测定，II期研究的目的是确定该试剂在急诊科的有效性，以便能够准确分诊急性心肌梗死患者的非心源性胸痛。拟议的商业应用：Tc-99 m葡萄糖二酸盐可用于鉴别急性心肌梗死患者。在急诊室建立这样的程序应该提供一个快速的规则和排除胸痛患者，并应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.