US2011318726A1PendingUtilityA1

Predicting coronary artery disease and risk of cardiovascular events

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Individually held — no corporate assignee on recordPriority: Mar 10, 2009Filed: Mar 10, 2010Published: Dec 29, 2011
Est. expiryMar 10, 2029(~2.6 yrs left)· nominal 20-yr term from priority
Inventors:Svati H. ShahChristopher B. NewgardWilliam E. KrausElizabeth R. HauserGeoffrey S. GinsburgL. Kristin Newby
H01J 49/0027G01N 2800/50G01N 2021/7786G01N 21/78G16H 50/30G01N 2800/324A61B 5/7275A61B 5/4866A61B 5/14546A61B 5/14532A61B 5/00Y10T436/201666Y10T436/174614Y10T436/200833G01N 33/6887
39
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Claims

Abstract

Methods of assessing the risk of cardiovascular disease in a subject by detecting the level of at least one metabolite in a sample from the subject are disclosed herein. The level of the metabolite is indicative of the risk of cardiovascular disease in the subject. The metabolites may be acylcarnitines, amino acids, ketones, free fatty acids or hydroxybutyrate. The cardiovascular disease may be risk of a cardiovascular event, presence of coronary artery disease or risk of development of coronary artery disease.

Claims

exact text as granted — not AI-modified
1 . A method for assessing risk of cardiovascular disease in a subject comprising:
 a) detecting the level of a least one metabolite in a sample from the subject, wherein the metabolite is selected from the group consisting of acylcarnitines, amino acids, ketones, free fatty acids and hydroxybutyrate; and   b) comparing the level of the metabolite in the sample to a standard, wherein the level of the metabolite in the subject is indicative of the risk of cardiovascular disease in the subject.   
     
     
         2 . A method for assessing the risk of cardiovascular disease in a subject, comprising:
 obtaining a sample from the subject;   providing the sample to a laboratory for detection of metabolite levels in the sample, wherein the metabolite is selected from acylcarnitines, amino acids, ketones, fatty acids and hydroxybutyrate; and   receiving from the laboratory a report indicating metabolite levels in the sample, wherein the level of the metabolite is indicative of the risk of cardiovascular disease in the subject.   
     
     
         3 . The method of  claim 1 , wherein the cardiovascular disease is a cardiovascular event and the level of the metabolite in the subject is indicative of the risk of a cardiovascular event in the subject. 
     
     
         4 . The method of  claim 3 , wherein the metabolite detected in step (a) is a short-chain dicarboxylacylcarnitine metabolite. 
     
     
         5 . The method of  claim 3 , wherein the metabolite detected in step (a) is selected from the group consisting of Gly, Ala, Ser, Pro, Met, His, Phe, Tyr, Asx, Glx, Ornithine, Citrulline, arg, C2, C3, C4:C14; C5:1, C5, C4:OH, C14-DC:C4DC, C5-DC, C6-DC, C10:3, C10, C10-53 OH:C8DC, C12:1, C12, C12-OH:C10DC, C14:1-OH, C14-OH:C12-DC, C16, C16-OH/C14-DC, C18:2, C18-OH/C16-DC, C20, C20:1-OH/C18:1-DC, C20-OH/C18-DC, C8:1-OH/C6:1-DC, C8:1-DC, C16:1, C16:1-OH/C14:1-DC, C20:4, FFA, HBUT, and Ket. 
     
     
         6 . The method of  claim 3 , wherein the metabolite detected in step (a) includes the metabolites of factor 8. 
     
     
         7 . The method of  claim 3 , wherein the metabolites detected in step (a) comprise citrulline, C5-DC, C6-DC, C8:1-OH/C6:1-DC, and C8:1-DC. 
     
     
         8 . The method of  claim 3 , wherein the metabolites detected in step (a) comprise ornithine, citrulline, C5, C14-DC:C4DC, C5-DC, C6-DC, C10-OH:C8DC, C8:1-OH/C6:1-DC, C8:1-DC, C20:4 and FFA. 
     
     
         9 . The method of  claim 1 , wherein the cardiovascular disease is coronary artery disease and the level of the metabolite in the subject is indicative of the presence of coronary artery disease in the subject. 
     
     
         10 . The method of  claim 9 , wherein the metabolite detected in step (a) is a medium-chain acylcarnitine, a branched chain amino acid or associated metabolite, or a metabolite associated with the urea cycle. 
     
     
         11 . The method of  claim 9 , wherein the metabolite detected in step (a) is selected from the group consisting of Pro, Leu/Ile, Met, Val, Glx, Citrulline, C2, C3, C4:Ci4; C5, C8, C8:1-OH/C6:1-DC, C10:1, C14:2, C14:1-OH, C16:2, C16:1, C16:2, C16:1, C16:1-OH/C14:1-DC, C18-OH/C16-DC, HBUT, and Ket. 
     
     
         12 . The method of  claim 9 , wherein the metabolite detected in step (a) includes the metabolites of at least one of factor 1, factor 4 or factor 9. 
     
     
         13 . The method of  claim 9 , wherein the metabolites detected in step (a) comprise Leu/Ile, Glx, 014:1-OH and C16:1-OH/C14:1-DC. 
     
     
         14 . The method of  claim 13 , wherein a level of Leu/Ile greater than 170 mM is indicative of coronary artery disease. 
     
     
         15 . The method of  claim 13 , wherein a level of GLx greater than 128 mM is indicative of coronary artery disease. 
     
     
         16 . The method of  claim 13 , wherein a level of 014:1-OH less than 0.013 uM is indicative of coronary artery disease. 
     
     
         17 . The method of  claim 13 , wherein a level of C16:1-OH/C14:1-DC less than 0.0089 uM is indicative of coronary artery disease. 
     
     
         18 . The method of  claim 13 , wherein the metabolites detected in step (a) further comprise C2, C5 and C18-OH/C16-DC. 
     
     
         19 . The method of  claim 1 , wherein the cardiovascular disease is coronary artery disease and the level of the metabolite in the subject is indicative of the risk of developing coronary artery disease in the subject. 
     
     
         20 . The method of  claim 19 , wherein the metabolites measured include the short- and medium-chain acylcarnitine metabolites, branched chain amino acids and urea cycle related metabolites. 
     
     
         21 . The method of  claim 19 , wherein the metabolites measured include ketones. arg, ornithine, citrulline, glx, ala, val, leu/ile, pro, C2, C14:1, C18:1, C5:1, C4-i4, C18, C10:1 and FFA. 
     
     
         22 . The method of  claim 1 , wherein the level of at least two metabolites is detected in step (a). 
     
     
         23 . The method of  claim 1 , wherein the sample is blood. 
     
     
         24 . The method of  claim 1 , wherein the level of the metabolite is detected using mass spectroscopy. 
     
     
         25 . The method of  claim 1 , wherein the level of the metabolite is detected using a colorimetric or fluorometric assay. 
     
     
         26 . A method of developing a treatment plan for a subject comprising using the comparison of step (b) of any of the preceding claims to develop a treatment plan based on the risk of cardiovascular disease in the subject.

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