Cardiovascular risk event prediction and uses thereof

a risk event and cardiac disease technology, applied in the field of cardiac disease risk event prediction, can solve the problem that the framingham equation is less useful for monitoring the change in risk of individuals, and achieve the effect of determining the risk associated with protein measurements more accurately and high cv events

Inactive Publication Date: 2016-03-31
MADRYN HEALTH PARTNERS LP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0020]As is discussed herein, one of the central functions of measuring risk for a cardiovascular event is to enable the assessment of progress in response to treatment and behavioral changes such as diet and exercise. Current risk prediction methods such as the Framingham equation, include clearly unresponsive clinical covariate information, key factors are the age and gender of the subject. This makes the Framingham equation less useful for monitoring the change in an individual's risk, although it may be accurate for a population. A novel feature of this CV event risk test is that it does not require age as a part of the prognostic model. The subject invention is based on the premise that, within the biology of aging, there are underlying biological factors which are more directly associated with risk, but which are variable between individuals and thus better used to assess risk than chronological age. The invention is premised on the belief that age itself is not a causal factor in the disease, and that age is acting as a surrogate or proxy for the underlying biology. While age is indeed prognostic of CV events, it cannot be used to assess individual improvement, and presumably the effect of age is mediated through biological function. This effect can be better determined through measurement of the relevant biology. In this invention, the proteins that are targeted are involved in the biology of the disease. Thus, the invention captures the biological information that is reflected in the correlation between age and risk of a CV event.
[0021]The strategy to identify proteins from multiple processes involved in cardiovascular disease necessitated choosing parameters that provided a wide range/diversity of

Problems solved by technology

This makes the Framingham equation less useful for monitoring the chang

Method used

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  • Cardiovascular risk event prediction and uses thereof
  • Cardiovascular risk event prediction and uses thereof
  • Cardiovascular risk event prediction and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

Exemplary Biomarker Detection Using Aptamers

[0221]An exemplary method of detecting one or more biomarkers in a sample is described, e.g., in Kraemer et al., PLoS One 6(10): e26332, and is described below. Three different methods of quantification: microarray-based hybridization, a Luminex bead-based method, and qPCR, are described.

Reagents

[0222]HEPES, NaCl, KCl, EDTA, EGTA, MgCl2 and Tween-20 may be purchased, e.g., from Fisher Biosciences. Dextran sulfate sodium salt (DxSO4), nominally 8000 molecular weight, may be purchased, e.g., from AIC and is dialyzed against deionized water for at least 20 hours with one exchange. KOD EX DNA polymerase may be purchased, e.g., from VWR. Tetramethylammonium chloride and CAPSO may be purchased, e.g., from Sigma-Aldrich and streptavidin-phycoerythrin (SAPE) may be purchased, e.g., from Moss Inc. 4-(2-Aminoethyl)-benzenesulfonylfluoride hydrochloride (AEBSF) may be purchased, e.g., from Gold Biotechnology. Streptavidin-coated 96-well plates may be...

example 2

Methods

Study Design and Sample Collection

[0237]Archived plasma samples from subjects with stable CHD were obtained from two well-known, independent cohort studies. The characteristics of the study population are shown in Table 1. We performed protein biomarker discovery and model training in 938 plasma samples from the Heart and Soul study, with subsequent follow-up of 10 years. See, e.g., Shlipak et al., Am J Med. 2008; 121:50-57; Whooley et al., JAMA. 2008; 300:2379-2388. We validated the model on 971 samples from HUNT3, a Norwegian prospective cohort study with follow-up of 5 years. See Krokstad et al., Int Epidemiol. 2013; 42:968-977. We used the Heart and Soul inclusion and exclusion criteria to select all the participants with stable CHD from the larger HUNT3 cohort for this analysis. The discovery plasma samples were representative of a well-controlled academic prospective study: subjects were fasted, samples collected at the same time of day and centrifuged and frozen at −80...

example 3

Results

Baseline Characteristics

[0300]The clinical characteristics of the two study populations at baseline are summarized in Table 12. As expected, known risk factors are significantly more prevalent in the groups with events. There were fewer overall events in HUNT3 than in Heart and Soul, due to shorter follow up; nonetheless, the populations were generally comparable in the event rates per unit time and the distribution of the event types. In Table 12, P-values are associated with Fisher's exact test for categorical covariates and the Mann-Whitney U test for continuous covariates. Continuous values summarized with median and inter-quartile range (IQR). The HUNT3 validation set was not designed as a CHD study and as a result some clinical information was not available and is marked N / A. Legends: BMI=body mass index; ACE=angiotensin converting enzyme; ARB=angiotensin receptor blocker; LDL-C=low density lipoprotein cholesterol; HDL-C=high density lipoprotein cholesterol; TG=triglyce...

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Abstract

Biomarkers, methods, devices, reagents, systems, and kits used to assess an individual for the prediction of risk of developing a Cardiovascular (CV) Event over a 1 to 5 year period are provided.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]The present application claims the benefit of priority under 35 U.S.C. §119 of International Application No. PCT / US2014 / 063714, filed Nov. 3, 2014, and U.S. Provisional Application No. 62 / 055,984, filed Sep. 26, 2014, each of which is incorporated by reference herein in its entirety for any purpose.FIELD OF THE INVENTION[0002]The present application relates generally to the detection of biomarkers and a method of evaluating the risk of a future cardiovascular event in an individual and, more specifically, to one or more biomarkers, methods, devices, reagents, systems, and kits used to assess an individual for the prediction of risk of developing a Cardiovascular (CV) Event over a 1 to 5 year period. Such Events include but are not limited to myocardial infarction, stroke, congestive heart failure or death.BACKGROUND[0003]The following description provides a summary of information relevant to the present application and is not an admission...

Claims

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Application Information

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IPC IPC(8): G06F19/00G01N33/68G06N7/00G16B20/20G16B40/20G16B40/30
CPCG01N33/6887G06F19/345G06N7/005G01N2800/32G06F19/24G01N2800/60G06F19/18C12Q1/6883C12Q2525/205G01N2800/50G16H50/20G16B20/00G16B40/00G01N33/6893G06Q40/08G16B40/30G16B20/20G16B40/20G01N33/5308G16B40/10G16H50/30G01N2333/4712G01N2333/4716G01N2333/515G01N2333/521G01N2333/8121G01N2333/96486G06N7/01G01N2333/52
Inventor STERLING, DAVIDKATO, SHINTAROBRODY, EDWARD N.WILLIAMS, STEPHEN A.
Owner MADRYN HEALTH PARTNERS LP
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