Development of Platelet & Coagulation Activation Assays

描述(由申请人提供)：拟议研究的目标是 建立一套基于免疫的血小板和凝血激活检测方法 这将有助于在护理点(即紧急情况)确定 房间/胸痛单位)如果患者确实经历了 血栓依赖型急性心肌梗塞。目前的诊断分析依赖于 心肌损伤的“晚期”标志物，如CKMB和TnL。CarePoint 诊断公司建议开发这项技术来确定“早期” 血小板活化的标志物(膜和可溶性P-选择素和GPIIb/LiIA) 和凝血激活(凝血酶原片段1.2和D-二聚体)以及 TNL在几分钟内将结果提供给医疗保健专业人员 在床边。根据以下评估，更快地建立正在进行的血栓形成 血小板和凝血激活标志物，将有助于诊断 发展急性心肌梗死，缩短从首次症状到首次干预的时间，如 以及对进入急救中心的胸部患者进行分流 疼痛和疑似急性心肌梗死。此外，对血小板的鉴别诊断 激活与凝血激活将有助于选择最 对患者进行适当的药物治疗。 建议的商业应用： 快速评估血小板依赖型急性冠脉综合征和继发性急性心肌梗死的诊断标准的必要性怎么强调都不为过。冠心病是心脏病的主要原因 今天美国死亡人数和550万名急诊科患者死亡 每年经历胸痛的人中，只有10%-15%的人真正经历了急性心肌梗死。然而， 60%的患者入院，尽管不到15%的患者患有急性心肌梗死。此外， 疑似急性心肌梗死患者的血小板和促凝剂的活化状态 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方法以及事实上确定患者是否真的经历了 血栓相关的心肌梗塞。这项研究的第一阶段将确立这部小说 检测血小板和凝血功能早期标志物的方法学及诊断价值 CarePoint心脏免疫分析仪将结合床边、护理点 免疫分析是在这项研究的第一阶段发展起来的。

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.