Diagnostic methods for cardiovascular diseases
Inventors
RHYNE, Rhonda Fay • MAGARET, Craig Agamemnon • STROBECK, John Edward • JANUZZI, Jr., James Louis
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-12146888-B2
Publication Date
2024-11-19
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 provides a method that uses biomarker levels to determine whether a patient suffers from obstructive coronary artery disease. A biological sample is obtained or having obtained and a biomarker assay is performed or having performed 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’s history of hypertension.
The method identifies a patient as having a score indicative of obstructive coronary artery disease, where the score is based on the biomarker levels and the patient’s history of hypertension. The disclosure further describes clinical variable inputs and score refinement, including the patient’s sex, the patient’s age, and the patient’s history of coronary intervention or coronary artery bypass graft.
After identification, at least one cardiac treatment is administered and is selected from cardiovascular disease pharmacologic agent, cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft. The specification also describes diagnostic and prognostic scoring embodiments, including obstruction thresholding and performance evaluation using ROC/AUC and classification metrics.
Claims Coverage
The independent claim coverage centers on one primary scoring-and-treatment method for obstructive coronary artery disease, and the combined items support two core inventive features: biomarker-based score calculation and treatment selection after score-indicative identification. Dependent refinements further specify biomarker composition, additional clinical variables, an obstruction threshold, and particular treatment modalities.
Biomarker-based score for obstructive coronary artery disease
Obtain a biological sample from the patient, perform a biomarker assay for kidney injury molecule-1, adiponectin, and either or both of troponin and midkine, and calculate a score based on the biomarker levels and the patient’s history of hypertension.
Score-indicative identification and treatment administration
Identify the patient as having a score indicative of obstructive coronary artery disease, where the score is based on the biomarker levels and the patient’s history of hypertension, and administer at least one cardiac treatment selected from a cardiovascular disease pharmacologic agent, cardiac catheterization, percutaneous coronary intervention, and coronary artery bypass graft.
Clinical variables incorporated into the score
The score is further based on one or more clinical variables comprising the patient’s sex, the patient’s age, and the patient’s history of coronary intervention or coronary artery bypass graft.
Severe obstruction threshold in the score-indicative identification
The score indicative of obstructive coronary artery disease is based on a patient having at least 70% obstruction in a major epicardial vessel.
Nitrate as the cardiovascular disease pharmacologic agent
The cardiovascular disease pharmacologic agent is a nitrate.
Overall, the claim coverage centers on calculating a hypertension-informed obstructive CAD score from kidney injury molecule-1, adiponectin, and troponin and/or midkine, using the resulting score to identify the patient and trigger administration of cardiac treatment options, with dependent claims refining biomarker panels, obstruction thresholding, clinical variables, and treatment selection.
Stated Advantages
Enables identification of patients as having a score indicative of obstructive coronary artery disease for subsequent administration of cardiac treatment.
Documented Applications
Diagnosis support for obstructive coronary artery disease using biomarker-based scoring with a specified obstruction threshold (e.g., major epicardial vessel obstruction).
Prognostic scoring for composite cardiovascular outcomes over defined time horizons using biomarker panels and time-to-event analyses.
Interested in licensing this patent?