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USE OF sCD14 OR ITS FRAGMENTS OR DERIVATIVES FOR RISK STRATIFICATION, DIAGNOSIS AND PROGNOSIS

Inactive Publication Date: 2015-12-03
MITSUBISHI CHEM MEDIENCE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention provides a method for evaluating a person's risk of developing cardiovascular disease or condition, atherosclerosis, or dying from a cardiovascular disease or condition. This method involves measuring the amount of a compound called sCD14, sCD14-ST, or a fragment or derivative of sCD14 in a sample from the person. By comparing the amount of the compound to a reference amount, the person's risk can be determined. The invention also provides a method for evaluating the effectiveness of treatments for cardiovascular disease or condition, such as antibiotics, probiotics, and lactulose. The method can be used to determine if a person needs to be hospitalized or if they will benefit from treatment. The invention also provides a method for evaluating the risk of a person developing a cardiovascular disease or condition by combining the results of measuring the compound with other markers, such as neurohormonal markers, regulators of water balance, ischemic cardiac markers, cytokines, inflammatory markers, and cellular adhesion molecules.

Problems solved by technology

Cardiovascular diseases can remain asymptomatic for long periods of time.
However, they may have severe consequences once an acute cardiovascular event, such as myocardial infarction (MI) or acute decompensated heart failure (ADHF), occurs.
The conventional diagnostic techniques, specifically for emergency situations, usually do not allow for a reliable diagnosis and / or risk assessment covering these various pathological states.
Further drawbacks are the lack of sufficient personnel for carrying out sophisticated diagnostic techniques and assays and the varying occupancy in emergency rooms.
At present, there does not exist a standardized diagnostic procedure covering the various cardiovascular diseases and conditions a physician may encounter in an emergency department.
Thus, a rapid and accurate diagnosis of cardiovascular diseases or conditions allowing a decision if the subject can be discharged (rule-out) or has to be admitted to the hospital (rule-in) for further examination or intensive care treatment (which can be live saving) cannot be performed in the emergency department with sufficient accuracy.
As a consequence thereof, many patients will either be wrongly admitted or wrongly discharged.

Method used

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  • USE OF sCD14 OR ITS FRAGMENTS OR DERIVATIVES FOR RISK STRATIFICATION, DIAGNOSIS AND PROGNOSIS
  • USE OF sCD14 OR ITS FRAGMENTS OR DERIVATIVES FOR RISK STRATIFICATION, DIAGNOSIS AND PROGNOSIS
  • USE OF sCD14 OR ITS FRAGMENTS OR DERIVATIVES FOR RISK STRATIFICATION, DIAGNOSIS AND PROGNOSIS

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0198]We herewith demonstrate that use of sCD14-ST improves detection of subjects at elevated risk for developing a cardiovascular disease or condition, diagnosis of acute coronary syndrome (ACS), acute myocardial infarction (MI), and acute heart failure (AHF) as well as decision making in the emergency room and the overall management of patients presenting to emergency departments by evaluating the diagnostic and prognostic power of sCD14-ST and prospectively examining the clinical impact of sCD14-ST concentration guided decision making regarding discharge, admission to hospital, intensive care treatment, prevention, and therapeutic measures in cardiovascular diseases or conditions. sCD14-ST was measured in samples obtained from a control group of healthy individuals and patients with different cardiac diseases:[0199]Chronic heart failure (HF), n=40[0200]Angina pectoris (AP) and unstable angina pectoris (UAP), n=17[0201]Non-ST-elevation myocardial infarction (NSTEMI), n=29[0202]Acu...

example 2

Reference Interval

[0206]A healthy control group (reference population) was used including 60 men and 59 women (age ranging from 21 to 69 years, median age 42 years) who fulfilled the following criteria: chronic diseases and intake of medications were excluded by questionnaire; physical examination, assessment of blood pressure, ECG registrations, and oral glucose tolerance tests yielded no pathological findings; plasma concentrations of N-terminal pro-B-type natriuretic peptide were ≦125 pg / ml; concentrations of TSH, creatinine and HbA1c were normal; cardiovascular diseases were excluded by cardiac magnetic resonance imaging including a dobutamine stress test.

[0207]sCD14-ST concentrations were determined in EDTA plasma samples of the control group using the PATHFAST assay. The 99th percentile upper reference limit (URL) according to the Clinical Laboratory Standard Institute (CLSI) Guideline C28-A3 was 258 (90% CI: 237-276) pg / ml. The results are displayed in Tab. 1.

TABLE 1sCD14-ST ...

example 3

sCD14-ST Levels in Patients with Chronic Heart Failure (CHF)

[0208]sCD14-ST concentrations were measured in EDTA plasma samples obtained from 40 patients with chronic heart failure (New York Health Association (NYHA) classification I-III).

TABLE 2sCD14-ST concentrations (pg / ml) in patients with CHF incomparison to the control groupControl groupCHF, NYHY I-IIISample size11940Lowest value 6083Highest value311533Median14316895% CI for the median133 to 150156 to 191Interquartile range115 to 174144 to 259Mann-Whitney test (independent samples)Average rank of first group68.9554Average rank of second group97.625Mann-Whitney U1395Test statistic Z (corrected for ties)3.536Two-tailed probabilityP = 0.0004

[0209]The sCD14-ST values were significantly (p=0.0004) elevated in CHF patients compared to the control group (Tab. 2). The ROC analysis (see Tab. 3) revealed an AUC of 0.689 (Sensitivity=70%, NPV=86%; Specificity=64%, PPV=41.2%) showing the discriminatory power of sCD14-ST between healthy con...

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Abstract

The present invention relates to a method for diagnosis of a cardiovascular disease or condition or atherosclerosis and for a method for evaluating the risk of a subject of developing the same. Methods are further provided for evaluating a subject's risk of mortality, for evaluating whether a subject will benefit from a certain treatment or whether a subject needs to be hospitalized or whether a subject may be discharged. The present invention provides sCD14 or a fragment or derivative thereof (including in particular sCD14-ST) as a novel marker for cardiovascular risk in general, more specifically as a marker for cardiovascular disease or condition, or atherosclerosis.

Description

FIELD OF THE INVENTION[0001]The present invention relates to the field of means for assessing a diagnosis or a prognosis with respect to cardiovascular diseases or conditions or atherosclerosis, and to methods for evaluating the cardiovascular or atherosclerotic risk of a subject.[0002]More specifically, the present invention relates to novel methods for diagnosing a cardiovascular disease or condition or atherosclerosis. sCD14, sCD14-ST, or a fragment or derivative of sCD14 other than sCD14-ST is provided as a novel marker for diagnosis of cardiovascular diseases or conditions or atherosclerosis. The present invention further comprises a method for the evaluation of a subject's risk of developing a future cardiovascular disease or condition or atherosclerosis. Furthermore, methods are provided for the diagnosis of an acute cardiac event in subjects showing signs of a cardiovascular disease or condition or atherosclerosis. Preferably, the method according to the present invention pe...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/6893G01N33/6872G01N2333/70596G01N2800/52G01N2800/50G01N2800/325G01N2800/324G01N2800/323G01N2800/56G01N2800/32A61P9/00A61P9/10
Inventor SPANUTH, EBERHARD
Owner MITSUBISHI CHEM MEDIENCE
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