Apparatus and methods for risk stratification of patients with chest pain of suspected cardiac origin

• US 20060135875A1
• Filed: 12/22/2005
• Published: 06/22/2006
• Est. Priority Date: 05/19/2003
• Status: Abandoned Application

• Current Assignee: Ischemia Technologies, Inc. (Abbott Laboratories Incorporated)
• Original Assignee: Ischemia Technologies, Inc. (Abbott Laboratories Incorporated)
• Inventors: Morris, Deborah L., Soane, Mark M., Crosby, Peter A.
• Application Number:
  US11/317,831
• Publication Number:
  US 20060135875A1
• Time in Patent Office: Days
• US Class Current: 600/509
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01N 2800/324 Coronary artery diseases, e.g. angina pectoris, myocardial infarction
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/56 Staging of a disease; Further complications associated with the disease
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

The subject invention relates to the detection, diagnosis and risk stratification of clinical events such as acute coronary syndrome, in patients with signs and symptoms of suspected cardiac origin. In one embodiment, a clinical event in a patient is diagnosed by obtaining the patient'"'"'s ECG, and at least one in vitro diagnostic assay, preferably an assay for a marker of ischemia, and optionally in vitro diagnostic assays for necrotic markers or other cardiac indicators, and combining the foregoing results in an algorithm to provide a diagnosis or a risk stratification of the clinical condition.

Claims

1. A method, comprising:

receiving at least one assay value indicative of a result of an in vitro assay for albumin that has been modified by exposure to ischemic tissue, the assay having been performed on a sample that includes material derived from a human;

receiving at least one electrocardiogram value indicative of an electrocardiogram obtained from the human; and

determining, based at least in part on the assay and electrocardiogram values, at least one diagnostic value indicative of a diagnosis or risk stratification of acute cardiac ischemia, acute coronary syndrome, or unstable angina of the human.

2. The method of claim 1, comprising determining, based at least in part on the at least one diagnostic value, a diagnosis or risk stratification of acute cardiac ischemia, acute coronary syndrome, or unstable angina of the human.

3. A method, comprising:

receiving at least one albumin assay value indicative of a result of a first in vitro assay for albumin that has been modified by exposure to ischemic tissue, the first assay having been performed on a sample that includes material derived from blood of a human;

receiving at least one necrosis assay value indicative of a result of a second in vitro assay for a marker of necrosis, the second assay having been performed on a sample that includes material derived from blood of the human;

receiving at least one electrocardiogram value indicative of an electrocardiogram obtained from the human; and

determining, based at least in part on the albumin assay, necrosis assay, and electrocardiogram values, at least one diagnostic value indicative of a diagnosis or risk stratification of acute coronary syndrome of the human.

4. The method of claim 3, comprising determining, based at least in part on the albumin assay, necrosis assay, and electrocardiogram values, a diagnosis or risk stratification of acute coronary syndrome of the human.

5. An apparatus, comprising:

an electrocardiogram device configured to obtain an electrocardiogram from a human and provide at least one electrocardiogram value indicative of the electrocardiogram;

an analysis device configured to receive a sample analysis strip and determine at least one assay value indicative of a result of an in vitro assay performed using the sample analysis strip; and

at least one of (a) a processor configured to receive the electrocardiogram and assay values and determine the presence of or probability that the human has a condition based at least in part on the electrocardiogram and assay values or (b) an output device configured to output at least one indication of the electrocardiogram and assay values.

6. The apparatus of claim 5, wherein the condition is selected from the group consisting of acute cardiac ischemia, acute coronary syndrome, or unstable angina of the human.