Apparatus and method for risk stratification of patients with chest pain of suspected cardiac origin
First Claim
1. A method for diagnosis of a clinical condition in a patient, said clinical condition selected from the group consisting of acute cardiac ischemia (ACI), acute coronary syndrome (ACS) or unstable angina (UA), or for risk stratification of a patient possibly with the condition, comprising the steps of:
- a) obtaining from the patient at least one sample of a substance stream which has been in contact with a tissue suspected of undergoing the clinical condition;
b) conducting at least a first in vitro diagnostic assay on the sample for albumin that has been modified by exposure to ischemic tissue and optionally additional in vitro diagnostic assays;
c) measuring and analyzing the patient'"'"'s electrocardiogram (ECG); and
d) applying an algorithm to combine the results of the assay(s) of step (b) and the electrocardiogram in step (c) using an algorithm to provide a positive or negative diagnosis or risk stratification of the clinical condition.
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Accused Products
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.
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Citations
35 Claims
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1. A method for diagnosis of a clinical condition in a patient, said clinical condition selected from the group consisting of acute cardiac ischemia (ACI), acute coronary syndrome (ACS) or unstable angina (UA), or for risk stratification of a patient possibly with the condition, comprising the steps of:
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a) obtaining from the patient at least one sample of a substance stream which has been in contact with a tissue suspected of undergoing the clinical condition; b) conducting at least a first in vitro diagnostic assay on the sample for albumin that has been modified by exposure to ischemic tissue and optionally additional in vitro diagnostic assays; c) measuring and analyzing the patient'"'"'s electrocardiogram (ECG); and d) applying an algorithm to combine the results of the assay(s) of step (b) and the electrocardiogram in step (c) using an algorithm to provide a positive or negative diagnosis or risk stratification of the clinical condition. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A method for diagnosis of an acute coronary syndrome (ACS) or for risk stratification of a patient with suspected ACS, comprising the steps of:
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a) obtaining at least one blood fraction sample from the patient; b) conducting at least one in vitro diagnostic assay for albumin that has been modified by exposure to ischemic tissue and at least one in vitro diagnostic assay for a marker of necrosis on the sample; c) measuring and analyzing the patient'"'"'s electrocardiogram (ECG); and d) combining the results of the assay(s) of step (b) and the ECG in step (c) using an algorithm to provide a positive or negative diagnosis of ACS or indication of the risk that the patient has ACS. - View Dependent Claims (23, 24, 25, 26, 27, 28, 29, 30, 31, 32)
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33. An apparatus for diagnosis of a clinical condition or estimating the probability of the presence of the condition in a patient, comprising:
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an electronic module housing comprising a display means;
a data entry and control means;
a means for measuring an electrocardiogram (ECG);
an aperture containing a reader means;
an analysis means in electrical continuity with the data entry and control means, the ECG means, and the reader means, whereby said analysis means can analyze signals from each said means;
a power source; and
optionally a link to a laboratory or hospital information system;wherein said aperture is adapted to receive a sample analysis strip for conducting an in vitro diagnostic assay on a patient sample of a substance stream, and said reader is adapted to read results of said assay; whereby said analyzer receives signals from said ECG means and said data entry and control means, and upon insertion of said strip into said aperture, from said reader means, and said analyzer means transmits analyzed results to said display means. - View Dependent Claims (34, 35)
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Specification