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

Tc-99m 葡萄糖酸用于急诊室胸痛分诊。

• 批准号: 7620389
• 负责人: Koon Y Pak
• 金额: $ 67.95万
• 依托单位: MOLECULAR TARGETING TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2011-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7620389
• 关键词: Accident and Emergency department; Acute; Acute myocardial infarction; Cardiac; Chest Pain; Clinical; Clinical Trials; Coronary; Coronary Arteriosclerosis; Coronary heart disease; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Imaging; Early Diagnosis; Emergency Situation; Evaluation; Event; Healthcare; Image; Infarction; Ischemia; Lead; Methods; Multi-Institutional Clinical Trial; Myocardial; Myocardial Infarction; Myocardial Ischemia; Myocardial perfusion; Myocardium; Necrosis; Nuclear; Patients; Pattern; Perfusion; Phase II Clinical Trials; Predictive Value; Radiopharmaceuticals; Recording of previous events; Research; Resources; Rest; Risk; Specificity; Stratification; Syndrome; Techniques; Triage; Unstable angina; acute coronary syndrome; diagnostic accuracy; pre-clinical; preclinical study; success; technetium Tc 99m glucarate; uptake

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.

描述（由申请人提供）：将急性冠状动脉综合征（AC）与非心脏胸痛区分开来是急诊科临床医生的主要诊断挑战。心肌灌注成像的研究表明了重要的信息，以进行风险分层稳定的ACS患者。但是，这种方法在先前的冠心病病史（CAD）的患者中具有有限的价值，因为这些患者通常会具有异常的静息灌注模式，从而排除了将旧梗塞与新缺血性事件区分开的能力。 99m TC-葡萄糖酸盐未检测到旧的心脏病发作，因此，应在成像可疑的ACS患者的特异性方面具有优势。十多年来，99m TC-葡萄糖酸葡萄糖酸葡萄糖酸葡萄糖酸盐一直是一种用于诊断急性心肌梗死（AMI）的放射性药物诊断成像剂。以前，该试剂被认为是坏死心肌或MI的特异性。然而，最近的临床前研究表明，即使在缺血的情况下，在缺血的情况下，也有99m TC-葡萄糖酸的摄取增加。这种扩展的特异性导致了以下假设：该成像剂可用于准确评估胸伴诊断患者的ACS的存在。拟议的II期临床试验的广泛目的是证明，核成像产品候选者（99MTC-葡萄糖酸盐）可用于诊断急诊室中冠状动脉疾病史的胸痛患者的ACS诊断。与临床放电诊断相比，将获得急诊科诊断为急诊室中ACS的准确性。该提案的具体目的是：1。在100例涉嫌ACS的胸痛患者中，对心脏成像进行了99mTC-葡萄糖酸酯的多站点临床试验，但没有明显的MI迹象，并且患有先前的冠状动脉疾病。 2。与标准临床放电诊断相比，确定99m TC-葡萄糖酸葡萄糖成像的准确性。这项研究的结果可以为患有冠心病患者的急性冠状动脉综合征的明确诊断提供技术进步。这不仅应该导致这些患者的早期诊断和分类，还应导致更好的医疗资源管理。