Method for determining onset risk of cardiovascular disease in subject, and method for determining vascular calcification in subject

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Solution Overview

Problem

Current methods for assessing cardiovascular disease risk and vascular calcification are inadequate, particularly in predicting the onset of cardiovascular diseases and quantifying vascular calcification, as they lack sensitive and specific biomarkers.

Innovation Solution

Measuring alkaline phosphatase activity in extracellular vesicles captured from a blood sample, using specific antibodies to detect proteins associated with vascular calcification, such as CD9, CD63, Annexin VI, and Pit1, to serve as indices for cardiovascular disease risk and vascular calcification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If CAC score based on CT image is used to evaluate vascular calcification, then the evaluation can be performed, but the method lacks sensitivity and specificity for predicting cardiovascular disease onset

Engineering Contradiction:

Improvedetection sensitivityVSAvoidpredictive accuracy

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The invention extracts and measures specific biomarkers (alkaline phosphatase activity in extracellular vesicles) from blood samples, separating the detection of early vascular calcification signals from the limitations of whole-organ imaging. This extraction approach enables sensitive detection of disease onset before structural changes become visible on CT scans.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention uses extracellular vesicles as intermediary carriers that transport alkaline phosphatase and other calcification-related proteins in the bloodstream. By measuring the activity of these intermediary molecules, the method detects early vascular calcification processes that occur before they manifest as detectable structural changes in coronary arteries.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If traditional cardiovascular risk factors are monitored, then general risk assessment can be performed, but specific vascular calcification quantification is not achieved

Engineering Contradiction:

Improvecalcification quantificationVSAvoidmethod complexity

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The invention replaces the mechanical imaging system (CT scanner) with a biochemical measurement system that detects alkaline phosphatase activity in extracellular vesicles. This substitution transforms the detection mechanism from visualizing structural changes to measuring enzymatic activity, enabling quantification of early calcification processes with simpler, more accessible laboratory equipment.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

3Loss of time

If early detection of cardiovascular disease is pursued, then preventive interventions can be implemented, but reliable biomarkers are currently unavailable

Engineering Contradiction:

Improvedetection timingVSAvoidbiomarker reliability

Core Design Contradiction:

Loss of timeVSMeasurement precision

Solution Approach 1:

The invention performs preliminary detection of vascular calcification by measuring alkaline phosphatase activity in extracellular vesicles before clinical symptoms or structural changes occur. This preliminary action enables early identification of individuals at risk, allowing preventive interventions to be implemented before disease progression.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The invention changes the measurement parameter from structural imaging metrics (CAC score) to biochemical activity metrics (alkaline phosphatase activity). This parameter change enables detection of early calcification processes at the molecular level, providing more timely and reliable biomarker information for disease onset prediction.

Inventive Principle:

Principle #35Parameter changes

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Provides a reliable and sensitive method for determining cardiovascular disease risk and vascular calcification by correlating alkaline phosphatase activity with CAC scores, enabling early detection and targeted medical interventions.

Implementation Method 1

capturing, on a solid phase, an extracellular vesicle derived from a blood sample

Methodology Applied

Scientific EffectAntibody-antigen binding:

Implementation Method 2

measuring alkaline phosphatase activity of the extracellular vesicle

Methodology Applied

Scientific EffectEnzyme catalysis: Enzyme

Data Source

PatentUS12474341B2Method for determining onset risk of cardiovascular disease in subject, and method for determining vascular calcification in subject

Publication Date: 2025.11.18 SYSMEX CORP

AI summary

Disclosed is a method of determining onset risk of cardiovascular disease in a subject, the method comprising:capturing, on a solid phase, an extracellular vesicle derived from a blood sample collected from the subject; andmeasuring alkaline phosphatase activity of the extracellular vesicle,a measured result of the alkaline phosphatase activity being directed for use as an index of the onset risk of cardiovascular disease in the subject.