Diagnostic methods for cardiovascular diseases

Inventors

RHYNE, Rhonda FayMAGARET, Craig AgamemnonSTROBECK, John EdwardJANUZZI, Jr., James Louis

Assignees

Prevencio Inc

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Publication Number

US-11977083-B2

Patent

Publication Date

2024-05-07

Expiration Date


Abstract

Compositions and methods are provided for diagnosis and/or prognosis of cardiovascular diseases or events in a subject. In some embodiments, the method includes measuring and comparing the level of particular proteins to other proteins. In other embodiments, the method includes comparison with clinical variable information.

Core Innovation

The invention relates to cardiovascular diagnosis and treatment selection by determining whether a patient at risk of cardiovascular disease or having chest pain or discomfort in the shoulder, arm, back, neck or jaw suffers from obstructive coronary artery disease. The determination is performed by obtaining or having obtained a biological sample and performing or having performed a biomarker assay on the biological sample for kidney injury molecule-1, adiponectin, and either or both of troponin and midkine.

A score is calculated based on the biomarker levels, and the patient is identified as having a score indicative of obstructive coronary artery disease. The score is used as a basis for deciding whether obstructive coronary artery disease is present, and when the patient is identified by the score as indicative, a therapeutic or diagnostic intervention regimen is selected.

The selected intervention includes administering at least one cardiac treatment selected from a cardiovascular disease pharmacologic agent, cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft. The document further refines the approach by specifying additional biomarkers and by optionally incorporating clinical variables into the score, and the score interpretation can be tied to an obstruction threshold for major epicardial vessel obstruction.

Claims Coverage

The independent claim covers a method for determining whether the patient suffers from obstructive coronary artery disease by biomarker-assay-based scoring, followed by selection of at least one cardiac treatment. Across the dependent refinements, the inventive features additionally constrain which biomarkers are assayed, how scoring is formed, and which quantitative obstruction or treatment options apply.

Biomarker assay panel for obstruction scoring

Performing or having performed a biomarker assay on the biological sample for kidney injury molecule-1, adiponectin, and either or both of troponin and midkine.

Score calculation based on biomarker levels

Calculating a score based on the biomarker levels.

Treatment selection based on score indicative of obstructive CAD

Identifying the patient as having a score indicative of obstructive coronary artery disease, then administering at least one cardiac treatment selected from a cardiovascular disease pharmacologic agent, cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft.

Optional inclusion of clinical variables in scoring

The score is based on the biomarker levels and one or more clinical variables.

Quantitative obstruction threshold interpretation

Identifying the patient as having at least 70% obstruction in a major epicardial vessel.

Biomarker panel refinement to include troponin and midkine

Performing a biomarker assay on a biological sample to test for kidney injury molecule-1, adiponectin, troponin, and midkine.

Narrowed treatment option: percutaneous coronary intervention

The at least one cardiac treatment is a percutaneous coronary intervention.

Representative pharmacologic agent: nitrate

The cardiovascular disease pharmacologic agent is a nitrate.

Overall claim coverage ties a determination of obstructive coronary artery disease to a score derived from a defined biomarker set and optionally clinical variables, and then links that determination to administration of selected cardiac treatments. Dependent refinements further constrain the biomarker panel, add a clinical-variable component to scoring, impose a quantitative major epicardial vessel obstruction threshold, and narrow eligible treatments to specified procedures or representative pharmacologic classes.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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