Development of Platelet & Coagulation Activation Assays

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.