Methods for assessing the risk for development of cardiovascular disease

Abstract

The present invention relates to diagnostic tests, methods and kits that are useful to assess a subject's risk of developing a pathologic condition related in part to the presence of HDL oxidation product. Measuring the quantity of one or more HDL oxidation products present in the blood is useful in evaluating risk for developing or evaluating the severity of a disease or evaluating response to treatment for such a disease as, for instance, cardiovascular disease.

1 - 25 . (canceled) 
     
     
         26 . A method for assessing efficacy of a therapy for treating a disease comprising the steps of:
 A) obtaining a biological sample from a subject;   B) measuring the amount of an high-density lipoprotein (“HDL”) oxidation product in the biological sample;   C) obtaining a second biological sample from the subject at a later time; and   D) comparing the amount of the HDL oxidation product in the biological sample with the amount of said HDL oxidation product present in the second biological sample.   
     
     
         27 . The method of  claim 26  wherein the HDL oxidation product is an apo A1 oxidation product. 
     
     
         28 . The method of  claim 26  wherein the disease is cardiovascular disease. 
     
     
         29 . The method of  claim 28 , wherein the cardiovascular disease is selected from the group consisting of atherosclerosis, coronary heart disease, ischemic heart disease, myocardial infarction, angina pectoris, peripheral vascular disease, cerebrovascular disease, and stroke. 
     
     
         30 . The method of  claim 26  wherein the disease is atherosclerosis. 
     
     
         31 . The method of  claim 26  wherein the disease is renal disease or renal failure. 
     
     
         32 . The method of  claim 26 , wherein the HDL oxidation product is selected from the group consisting of 3-nitrotyrosine, 3,5-dinitrotyrosine, 3-chlororotyrosine, nitrophenyl alanine, chlorophenyl alanine, o′,o′-dityrosine, ortho-tyrosine, meta-tyrosine, WG-4 (cross-linked tryptophan-glycine), oxo-tryptophan, p-hydroxyphenylacetic acid (pHA), and pHA adducts of lysine or lipids. 
     
     
         33 - 43 . (canceled) 
     
     
         44 . The method of  claim 26 , wherein said biological sample is selected from the group consisting of whole blood cells, whole blood cell lysates, erythrocytes, white blood cells, plasma, serum, urine, CSF and saliva. 
     
     
         45 . The method of  claim 26 , wherein said biological sample is plasma or urine. 
     
     
         46 . The method of  claim 26 , wherein measuring said HDL oxidation product is performed by immunoassay or flow cytometry. 
     
     
         47 . The method of  claim 46 , wherein said measuring is performed by a method selected from the group consisting of an enzyme-linked immunosorbent assay (ELISA), a lateral flow assay, a fluorescent polarization assay, a time-resolved fluorescence assay, a microparticle capture assay, a capillary electrophoresis assay, HPLC and a fluorescence immunoassay. 
     
     
         48 . The method of  claim 28 , wherein said subject is undergoing treatment with an agent useful in the treatment of cardiovascular disease.