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

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.

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.