Tc-99m Glucarate for chest pain triage in emergency room.

描述（由申请人提供）：区分急性冠状动脉综合征（ACS）与非心源性胸痛是急诊科临床医生的主要诊断挑战。心肌灌注成像的研究已经证明了对稳定的ACS后患者进行风险分层的重要信息。然而，这种方法在有冠心病（CAD）既往史的患者中的价值有限，因为这些患者通常具有异常的静息灌注模式，无法区分旧的梗死和新的缺血事件。99 m Tc-葡萄糖二酸盐不能检测陈旧性心脏病发作，因此，应该为既往CAD的疑似ACS患者成像提供特异性优势。99 mTc-葡萄糖二酸盐作为放射性药物诊断显像剂用于急性心肌梗死（AMI）的诊断已有十多年的历史。以前认为该药物对坏死心肌或MI具有特异性。然而，最近的临床前研究表明，99 m Tc-葡萄糖二酸盐摄取增加，在设置的缺血，即使在没有坏死。这种扩大的特异性导致了这样的假设，即这种显像剂可用于准确地评估ACS的存在，在胸痛患者与可疑的诊断。拟议的II期临床试验的主要目的是证明核成像候选产品99 mTc-葡萄糖二酸盐可用于急诊科有冠心病既往史的胸痛患者的ACS诊断。将通过与临床出院诊断进行比较，获得急诊科使用99 mTc-葡萄糖二酸盐诊断ACS的准确性。该提案的具体目标是：1。在100例疑似ACS但无明显MI体征且既往有冠状动脉疾病的胸痛患者中进行99 mTc-葡萄糖二酸盐心脏成像的多中心临床试验。2.确定99 m Tc-葡萄糖二酸盐成像与标准临床出院诊断相比的准确性。本研究结果可为确诊冠心病患者的急性冠状动脉综合征的确诊提供技术进步。这不仅会导致这些患者的早期诊断和分流，而且还应该导致更好的医疗资源管理。

DESCRIPTION (provided by applicant): Differentiating acute coronary syndrome (ACS) from noncardiac chest pain is the primary diagnostic challenge for clinicians in the emergency department. Studies of myocardial perfusion imaging have demonstrated important information for risk- stratifying stable post-ACS patients. However, this method is of limited value in patients with prior history of coronary heart disease (CAD), since these patients will often have abnormal resting perfusion patterns precluding the ability to differentiate old infarcts from new ischemic events. 99m Tc-glucarate does not detect old heart attacks, and thus, should provide an advantage in the specificity for imaging suspected ACS patients with previous CAD. 99m Tc-glucarate has been in development as a radiopharmaceutical diagnostic imaging agent for the diagnosis of acute myocardial infarct (AMI) for more than a decade. Previously the agent was thought to be specific for necrotic myocardium or MI. However, more recent preclinical studies suggested that 99m Tc-glucarate uptake is increased in the setting of ischemia, even in the absence of necrosis. This expanded specificity has led to the hypothesis that this imaging agent could be used to accurately assess the presence of ACS in the chest-pain patient with equivocal diagnosis. The broad aim of the proposed phase II clinical trial is to demonstrate that the nuclear imaging product candidate, 99mTc-glucarate, can be used in the diagnosis of ACS in chest pain patients with prior history of coronary heart disease in the setting of the emergency department. The accuracy of diagnosis of ACS in the emergency department with 99mTc-glucarate will be obtained by comparison to the clinical discharge diagnosis. Specific aims of the proposal are: 1. Conduct a multi-site clinical trial of cardiac imaging with 99mTc-glucarate in 100 chest pain patients suspected of ACS, but with no obvious signs of MI and having prior coronary artery disease. 2. Determine the accuracy of 99m Tc-glucarate imaging compared to standard clinical discharge diagnosis. Results from this research could provide a technological advancement in definitive diagnosis of acute coronary syndrome in patients with know coronary heart disease. This should not only lead to early diagnosis and triage of these patients but also should lead to better health care resource management.