Development of Platelet & Coagulation Activation Assays

描述（由申请人提供）：拟议研究的目标是 开发一组基于免疫的血小板和凝血激活试验 这将有助于在护理点（即紧急情况）确定 室/胸痛单元），如果患者确实正在经历 血栓依赖性急性心肌梗死目前的诊断测定依赖于 心肌损伤的"晚期"标志物，如CKMB和TnI。carepoint 诊断公司建议开发技术，以确定"早期" 血小板活化标志物（膜和可溶性P-选择素和GPIIb/IIIa） 和凝血激活（凝血酶原片段1.2和D-二聚体）以及 TNL的结果提供给卫生保健专业人员在几分钟内， 床边通过以下指标评估，更快速地建立持续血栓形成 血小板和凝血活化标志物，将有助于诊断 发展AMI，并缩短从首次出现症状到首次干预的时间， 以及帮助进入急诊中心的胸部疾病患者进行分诊， 疼痛和疑似AMI。此外，血小板的鉴别诊断 激活与凝固激活将有助于选择最 为患者提供适当的药物治疗。 拟定商业应用： 在快速评估血小板依赖性ACS和随后的AMI中，对诊断标准的需求不能被夸大。 冠心病是导致心脏病的主要原因 今天美国的死亡人数和急诊科收治的550万患者 每年经历胸痛，只有10 - 15%的人真正经历了AMI。 但是，在这方面， 60%的患者入院治疗，尽管只有不到15%的患者患有AMI。此外，委员会认为， 在疑似AMI患者中， 血液中的蛋白质是未知的，因此这种激活的诊断标准将有助于 医生在设计及时的治疗和实际上确定病人是否真正经历 血栓相关的心肌梗死 这项研究的第一阶段将建立小说 测量血小板和凝血"早期"标记物的方法学和诊断效用 CarePoint心脏免疫分析仪，将结合床旁、床旁 免疫分析在本研究的第一阶段开发。

DESCRIPTION (provided by applicant): The goal of the proposed research is to develop a panel of immuno-based platelet and coagulation activation assays which will be useful in determining at the point-of-care (i.e. emergency room/chest pain unit) if the patient is indeed experiencing a thrombus-dependent acute myocardial infarct. Current diagnostic assays rely on "late" markers of myocardial injury such as CKMB and Tnl. CarePoint Diagnostics, Inc. proposes to develop the technology to determine "early" markers of platelet activation (membrane and soluble P-selectin and GPIIb/lIIa) and coagulation activation (prothrombin fragment 1.2 and D-dimer) as well as Tnl with results provided to health care professionals in minutes at the bedside. More rapid establishment of ongoing thrombus formation, as assessed by platelet and coagulation activation markers, will facilitate diagnosis of evolving AMI and reduce the time from first symptoms to first intervention as well as aid in triage of patients entering emergency care centers with chest pain and suspected AMI. Furthermore, differential diagnosis of platelet activation vs. coagulation activation will aid in selection of the most appropriate pharmacological therapy for the patient. PROPOSED COMMERCIAL APPLICATION: The need for diagnostic criteria in the rapid assessment of platelet-dependent ACS and subsequent AMI cannot be overstated. Coronary heart disease is the leading cause of death in the U.S. today and of 5.5 million patients admitted to the emergency department each year experiencing chest pain, only 10-15% are actually experiencing AMI. However, 60% of patients are admitted to the hospital even though less than 15% have AMI. Furthermore, of those patients with suspected AMI, the activation state of blood platelets and procoagulant proteins in the blood is unknown and thus diagnostic criteria of such activation would aid physicians in designing timely therapy and in fact determining if patients were truly experiencing a thrombus-related myocardial infarction. Phase I of this research will establish the novel methodology and diagnostic utility of measuring "early" markers of platelet and coagulation CarePoint Cardiac Immuno Analyzer which will incorporate the bedside, point-of-care immunoassays developed in Phase I of this research.