US2022412991A1PendingUtilityA1

Identification of patients with abnormal fractional shortening

Assignee: ROCHE DIAGNOSTICS OPERATIONS INCPriority: Sep 12, 2012Filed: Aug 19, 2022Published: Dec 29, 2022
Est. expirySep 12, 2032(~6.1 yrs left)· nominal 20-yr term from priority
G01N 33/82G01N 2333/4706G01N 2333/4712G01N 2333/50G01N 33/6887G01N 2800/50G01N 2800/32G01N 2800/329A61B 8/0883G01N 2333/78G01N 2333/4703A61B 5/055
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Claims

Abstract

The present invention relates to a method for assessing whether a subject shall be subjected to an imaging based diagnostic assessment. The method is based on the determination of the amount(s) of a cardiac Troponin and/or Fibroblast Growth Factor 23 (FGF-23) in a sample from the subject, and on the comparison of the, thus, determined amount(s) with a reference amount (reference amounts). The present invention also relates to a system for performing an assessment whether a subject shall be subjected to an imaging based diagnostic assessment and to reagents and kits used in performing the methods disclosed herein. Moreover, the present invention is directed to a method for predicting the risk of mortality and/or of a cardiovascular event. Also encompassed is a method for diagnosing an early stage of LVH in a subject having a preserved left ventricular ejection.

Claims

exact text as granted — not AI-modified
1 . (canceled) 
     
     
         2 . A method for predicting the risk of mortality and/or a cardiovascular event in a subject who does not suffer from heart failure and/or who does not show overt signs of heart failure said method comprising the steps of
 a) determining, in a sample from said subject, the amount of IGFBP7 and/or the amount of FGF-23, and   b) comparing the amount (or the amounts) as determined in step a) to a reference amount (or to reference amounts), whereby the risk of mortality and/or a cardiovascular event in said subject is predicted.   
     
     
         3 . The method of  claim 2 , wherein the subject has a preserved LVEF (Left ventricular ejection fraction). 
     
     
         4 . The method of  claim 2 , wherein the LVEF is larger than 55%. 
     
     
         5 . The method of  claim 2 , wherein the LVEF is larger than 60%. 
     
     
         6 . The method of  claim 2 , wherein the method comprises the determination of the amount of FGF-23, and wherein the method further comprises the determination of the amount of vitamin D, the calculation of a ratio between the amounts of FGF-23 and vitamin D, and the comparison of the ratio to a reference ratio. 
     
     
         7 . The method of  2 , wherein step a) further comprises determining the amount of a brain natriuretic peptide and/or the amount of a cardiac Troponin in the sample from the subject. 
     
     
         8 . The method of  claim 7 , wherein the brain natriuretic peptide is selected from the group consisting of B-type natriuretic peptide (BNP) or N-terminal (NT)-pro hormone BNP (NT-proBNP). 
     
     
         9 . The method of  claim 7 , wherein the cardiac Troponin is selected from the group consisting of Troponin T or Troponin I. 
     
     
         10 . The method of  claim 2 , wherein the subject who does not show overt signs of heart failure suffers from heart failure classified as stage A or stage B according to the ACC/AHA classification, or wherein the subject is healthy with respect to cardiac diseases and disorders. 
     
     
         11 . The method of  claim 2 , wherein the sample is a blood, serum or plasma sample. 
     
     
         12 . The method of  claim 2 , wherein the subject is a human. 
     
     
         13 . The method of  claim 12 , wherein the subject is female. 
     
     
         14 . The method of  claim 2 , wherein the reference amount is derived from a subject or group of subjects known to have an elevated risk of mortality and/or of a cardiovascular event. 
     
     
         15 . The method of  claim 13 , wherein an amount of the marker FGF-23 and/or an amount of IGFBP7 which is (are) essentially identical or which is (are) larger than the reference amount(s) indicates that the subject to be tested is at elevated risk of mortality and/or of a cardiovascular event. 
     
     
         16 . The method of  claim 2 , wherein the reference amount is derived from a subject or group of subjects known to have reduced risk of mortality and/or of a cardiovascular event. 
     
     
         17 . The method of  claim 16 , wherein an amount of the marker FGF-23 and/or an amount of IGFBP7 which is (are) essentially identical or which is (are) lower than the reference amount(s) indicates that the subject to be tested is at reduced risk of mortality and/or of a cardiovascular event. 
     
     
         18 . The method of  claim 2 , wherein the risk of mortality and/or a cardiovascular event within four or five years is predicted.

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