Diagnosis of cardiovascular disease

• US 10,203,339 B2
• Filed: 05/01/2007
• Issued: 02/12/2019
• Est. Priority Date: 05/01/2006
• Status: Active Grant

• Current Assignee: Critical Care Diagnostics Inc.
• Original Assignee: Critical Care Diagnostics Inc.
• Inventors: Snider, James V., Jacobson, Sven
• Primary Examiner(s): Szperka, Michael
• Application Number:
  US12/299,177
• Publication Number:
  US 20100009356A1
• Time in Patent Office: 4,305 Days
• Field of Search: None
• CPC Class Codes: G01N 2333/7155 for interleukins [IL]
• CPC Class Codes: G01N 2800/226 Thrombotic disorders, i.e. thrombo-embolism irrespective of location/organ involved, e.g. renal vein thrombosis, venous thrombosis
• CPC Class Codes: G01N 2800/32 Cardiovascular disorders
• CPC Class Codes: G01N 2800/325 Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/6869 Interleukin
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere

Abstract

This invention relates to methods for the detection of cardiovascular disease, e.g., acute coronary syndrome, heart failure and/or pulmonary embolism, in high body mass index (BMI) individuals, e.g., with a BMI of 25-29, or 30 or above, and those with impaired renal function.

Claims

1. A method of diagnosing heart failure in a subject who has one or both of a body mass index (BMI) of greater than or equal to 25, and impaired renal function, and treating the subject, the method comprising:

(a) one or both of;

(i) determining the subject'"'"'s BMI, and if the subject'"'"'s BMI is equal to or greater than 25, selecting the subject; and

(ii) evaluating the subject'"'"'s renal function, and if the subject has impaired renal function, selecting the subject;

(b) performing an immunoassay to determine a level of brain natriuretic peptide (BNP) and a level of soluble ST2 in a biological sample from the selected subject;

(c) identifying a selected subject having a BNP level of between 100 pg/mL and 500 pg/mL, and an elevated level of soluble ST2 as compared to a reference level of soluble ST2 as having heart failure; and

(d) administering a pharmaceutical treatment for heart failure to the identified subject.

2. The method of claim 1, wherein the biological sample comprises blood, plasma, or serum.

3. The method of claim 1, wherein the reference level of soluble ST2 represents a level of soluble ST2 in a subject who does not have heart failure.

4. The method of claim 2, wherein the reference level of soluble ST2 is about 0.2 ng/mL of serum, and values above that level indicate, in part, the presence of heart failure.

5. The method of claim 1, further comprising performing an assay to determine a level of one or more other biomarkers in the subject.

6. The method of claim 5, wherein the one or more other biomarkers are selected from the group consisting of atrial natriuretic peptide (ANP), N-terminal-proANP, troponin, C-reactive protein, creatinine, Blood Urea Nitrogen, liver function enzymes, and albumin.

7. The method of claim 1, wherein determining whether the subject has impaired renal function comprises determining glomerular filtration rate (GFR) and/or serum creatinine level, and determining that the subject has impaired renal function if they have a GFR or serum creatinine level as shown in the following table:

8. The method of claim 1, wherein the subject has a BMI of greater than or equal to 30.

9. The method of claim 1, wherein the subject has a BMI of 25 to 29.

10. The method of claim 1, wherein the immunoassay is an enzyme-linked immunosorbent assay (ELISA).

11. A method of diagnosing heart failure in a subject who has impaired renal function, and treating the subject, the method comprising:

(a) evaluating the subject'"'"'s renal function, and if the subject has impaired renal function, selecting the subject;

(b) performing an immunoassay to determine a level of soluble ST2 in a biological sample from the selected subject;

(c) identifying a selected subject having an elevated level of soluble ST2 as compared to a reference level of soluble ST2 as having heart failure; and

(d) administering to the identified subject a pharmaceutical treatment for heart failure.

12. The method of claim 11, wherein the reference level of soluble ST2 represents a level in a subject who does not have heart failure.

13. The method of claim 11, wherein the reference level of soluble ST2 is about 0.2 ng/mL of serum, and values above that level indicate that the subject has heart failure.

14. The method of claim 11, wherein the biological sample comprises blood, plasma, or serum.

15. The method of claim 11, further comprising performing an assay to determine a level of one or more other biomarkers in the subject.

16. The method of claim 15, wherein the one or more other biomarkers are selected from the group consisting of:

brain natriuretic peptide, D-Dimer, atrial natriuretic peptide (ANP), N-terminal-proANP, troponin, C-reactive protein, creatinine, Blood Urea Nitrogen, liver function enzymes, and albumin.

17. The method of claim 11, wherein determining whether the subject has impaired renal function comprises determining glomerular filtration rate (GFR) and/or serum creatinine level, and determining that the subject has impaired renal function if they have a GFR or serum creatinine level as shown in the following table:

18. The method of claim 11, wherein the immunoassay is an enzyme-linked immunosorbent assay (ELISA).