Cardiovascular risk evaluations using a risk parameter that includes an HDL and inflammatory biomarker interaction parameter
Inventors
Otvos, James D. • Shalaurova, Irina Y.
Assignees
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Publication Number
US-11988679-B2
Publication Date
2024-05-21
Expiration Date
Abstract
Methods, systems and circuits evaluate a subject's CVD risk using a risk parameter that includes at least one HDL and inflammatory biomarker interaction parameter. The inflammatory biomarker may optionally comprise NMR derived measurements of GlycA from at least one biosample of the subject. The risk parameter may be gender-specific.
Core Innovation
The invention provides a method and related systems for determining a risk parameter for cardiovascular disease (CVD) or events by combining Nuclear Magnetic Resonance (NMR) measurements of HDL particles with the inflammatory biomarker GlycA. The approach uses an in vitro biosample comprising blood, plasma, or serum from a subject, and an NMR spectrum is provided for the subject’s sample. HDL particle size subclass measurements and GlycA are used to derive NMR-derived concentrations for at least one HDL particle size subclass and GlycA.
The invention programmatically calculates a composite CVD risk parameter ((HxI)CVD) using NMR-derived concentrations for an HDL particle size subclass and GlycA. The composite risk parameter is expressed using mathematical model coefficients and includes interaction terms involving GlycA and HDL particle size subclass concentrations, such as INFLAM and interaction terms INTERH1 and/or INTERH8. This calculation structure supports gender-specific multimarkers based on HDL-inflammation associations derived from GlycA × HDL subclass interactions.
The invention further includes embodiments in which HDL particle size subclasses are defined using a defined set of subclasses, including approaches with at least eight subclasses, and/or specific subclasses such as cH1 and cH8. In these embodiments, NMR spectral processing includes determining NMR-derived concentrations for HDL particle size subclasses and GlycA, and these concentrations are used to compute (HxI)CVD. Reporting and system embodiments are described for electronically providing the calculated risk parameter value to a medical professional and/or generating a patient report, including monitoring over time.
Claims Coverage
The partial content provides three independent claims, each centering on determining a cardiovascular disease risk parameter ((HxI)CVD) from NMR-derived HDL particle size subclass concentrations and the inflammatory biomarker GlycA, with at least one interaction parameter between GlycA and HDL subclass information.
NMR-based composite HDL-inflammation CVD risk parameter calculation
providing a Nuclear Magnetic Resonance (NMR) spectrum of an in vitro biosample comprising blood, plasma, or serum from a subject; obtaining measurements of HDL particles and inflammatory biomarker GlycA in the biosample; determining NMR-derived concentrations for an HDL particle size subclass and GlycA, based on the measurements; programmatically calculating a risk parameter value ((HxI)CVD) of the subject using the NMR-derived concentrations for the HDL particle size subclass and GlycA; and determining the subject's risk of having and/or developing CVD based, at least in part, on the (HxI)CVD risk parameter value.
System with NMR spectrometer and processor for composite CVD risk parameter
a Nuclear Magnetic Resonance (NMR) spectrometer configured to acquire an NMR signal of an in vitro biosample comprising blood, plasma, or serum from a subject; and a processor in communication with the NMR spectrometer, the processor configured to: determine NMR-derived concentrations from the NMR signal for an HDL particle size subclass and inflammatory biomarker GlycA; and programmatically calculate a risk parameter ((HxI)CVD) of the subject using the concentrations for the HDL particle size subclass and inflammatory biomarker GlycA.
Computer program product with HDL subclass and GlycA interaction-based CVD risk calculation
a non-transitory computer readable storage medium having computer readable program code embodied in the medium, the computer-readable program code comprising: computer readable program code that obtains NMR-derived measurements for at least eight subclasses of HDL-P in a blood, plasma, or serum sample and inflammatory biomarker GlycA; computer readable program code that determines concentrations of HDL particle size subclasses and/or inflammatory biomarker GlycA using the NMR-derived measurements; and computer readable program code that calculates a risk parameter ((HxI)CVD) comprising at least one interaction parameter.
Across the independent claims, the coverage is directed to generating NMR-derived concentrations for HDL particle size subclasses and GlycA from an in vitro biosample and then programmatically calculating a composite CVD risk parameter ((HxI)CVD). The claims’ core novelty is the risk parameter computation based on HDL subclass concentrations and GlycA, including interaction-parameter functionality, and the determination of CVD risk using that computed (HxI)CVD value.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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