Assessing whether a subject shall be subjected to imaging based diagnostic

Patent metadata

Field	Value
Publication number	US-11454634-B2
Application number	US-201815911699-A
Country	US
Kind code	B2
Filing date	Mar 5, 2018
Priority date	Sep 12, 2012
Publication date	Sep 27, 2022
Grant date	Sep 27, 2022

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.

First claim

The invention claimed is:

1. A method for assessing abnormal midwall fractional shortening in a subject suffering from hypertension wherein the subject does not have left ventricular hypertrophy (LVH), said method comprising the steps of
a) determining the amount(s) of a cardiac Troponin and/or Fibroblast Growth Factor 23 (FGF-23) in a serum or plasma sample from the subject,
b) comparing the determined amount in step (a) to a reference amount,
c) identifying the subject to be subjected to an imaging based diagnostic assessment for diagnosing abnormal midwall fractional shortening when an amount of a cardiac Troponin and/or FGF-23 in the sample as set forth in step a) is larger than the reference amount, and
d) subjecting the subject identified in step c) to said imaging based assessment for diagnosing abnormal midwall fractional shortening, thereby detecting the presence or absence of abnormal midwall fractional shortening.

2. The method of claim 1 wherein cardiac Troponin is determined in step a).

3. The method of claim 1 wherein FGF-23 is determined in step a).

4. The method of claim 1 wherein both cardiac Troponin and FGF-23 are determined in step a).

5. The method of claim 1 wherein the cardiac Troponin is Troponin T or Troponin I.

6. The method of claim 1 , wherein the reference amount is a calculated reference amount.

7. The method of claim 1 , wherein
the reference amount is derived from a subject or group of subjects which is (are) known to be susceptible to an imaging based diagnostic assessment, wherein an amount of the cardiac Troponin and/or FGF-23 which is (are) essentially identical or which is (are) larger than the reference amount(s) identifies (identify) that the subject shall be subjected to an imaging based diagnostic assessment.

8. The method of claim 1 , wherein the reference amount is the amount of the cardiac Troponin and/or FGF-23 in a first sample that has been obtained from the subject prior to the sample as set forth in step a) of claim 1 .

9. The method of claim 8 , wherein the first sample has been obtained 6 to 18 months prior to the sample as set forth in step a) of claim 1 .

10. The method of claim 8 , wherein an amount of a cardiac Troponin in the sample as set forth in step a) of claim 1 that is at least 10% larger than the amount in the first sample, and/or wherein an amount of FGF-23 in the sample as set forth in step a) of claim 1 is at least 5% larger than the amount in the first sample identifies (identify) that the subject shall be subjected to an imaging based diagnostic assessment.

11. The method of claim 8 , wherein the subject did not suffer from abnormal MFS at the time at which the first sample has been obtained.

12. The method of claim 1 , wherein the imaging based assessment is echocardiography or magnetic resonance imaging.

13. The method of claim 1 , wherein steps a) through c) are performed using a system comprising:
a) an analyzer unit configured to bring the sample into contact with a detection agent that specifically binds to cardiac Troponin for a time sufficient to allow for the formation of a complex of said detection agent and cardiac Troponin from the sample and/or a detection agent that specifically binds to FGF-23 for a time sufficient to allow for the formation of a complex of said detection agent and FGF-23 from the sample,
b) an analyzer unit configured to measure the amounts of the formed complexes, wherein said amounts of the formed complexes are proportional to the amounts of the cardiac Troponin and/or FGF-23,
c) a computing device having a processor and in operable communication with said analyzer units, and
d) a non-transient machine readable media including a plurality of instructions executable by the processor, wherein the instructions when executed transform the amount of the formed complexes into amount(s) of the cardiac Troponin and/or FGF-23 in the sample and compare said amount(s) to reference(s).

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Block Dirk
• Latini Roberto
• Masson Serge
• Wienhues-Thelen Ursula-Henrike
• Zaugg Christian

Classifications

• A61B8/0883

  for diagnosis of the heart · CPC title

• G01N2800/32

  Cardiovascular disorders · CPC title

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• G01N33/6887 Primary

  from muscle, cartilage or connective tissue · CPC title

• G01N2333/4712

  Muscle proteins, e.g. myosin, actin, protein · CPC title