Cellular fibronectin as a diagnostic marker in stroke and methods of use thereof
First Claim
1. A method of determining presence or risk of cerebral injury in a human subject, the method comprising:
- obtaining a test sample from a human subject;
analyzing the obtained test sample for presence or amount of (1) cellular fibronectin and (2) one or more additional markers both proteomic and non-proteomic for, or mass spectrometry peak levels of, any of apoptosis, cellular adhesion, cellular injury, coagulation, glial activation, inflammatory mediation, myelin breakdown, thrombosis, vascular damage, and specific and non-specific markers of cerebral injury; and
then correlating (1) the presence or amount of said cellular fibronectin and said more additional markers or peak levels, with (2) clinical patient information, other than the cellular fibronectin and additional makers or peak levels for cerebral injury, in order to deduce a probability of present or future risk of a cerebral injury for the subject.
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Abstract
Methods for the diagnosis and evaluation of stroke and stroke sub-type employ a variety of bio-markers including cellular fibronectin (c-Fn) assembled as a panel for stoke diagnosis and evaluation. Methods are disclosed for selecting markers and correlating their combined levels with a clinical outcome of interest. In various aspects the methods permit early detection and differentiation of stroke subtypes, determination of the prognosis of a patient presenting stroke symptoms, and identification of a patient at risk for early hematoma growth and/or malignant massive cerebral artery infarction. The disclosed methods provide rapid, sensitive and specific assays to greatly increase the number of patients that can receive beneficial stroke treatment and therapy, and to reduce the human and economic costs associated with incorrect stroke diagnosis.
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Citations
28 Claims
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1. A method of determining presence or risk of cerebral injury in a human subject, the method comprising:
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obtaining a test sample from a human subject;
analyzing the obtained test sample for presence or amount of (1) cellular fibronectin and (2) one or more additional markers both proteomic and non-proteomic for, or mass spectrometry peak levels of, any of apoptosis, cellular adhesion, cellular injury, coagulation, glial activation, inflammatory mediation, myelin breakdown, thrombosis, vascular damage, and specific and non-specific markers of cerebral injury; and
thencorrelating (1) the presence or amount of said cellular fibronectin and said more additional markers or peak levels, with (2) clinical patient information, other than the cellular fibronectin and additional makers or peak levels for cerebral injury, in order to deduce a probability of present or future risk of a cerebral injury for the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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21. A kit for determining presence or risk of cerebral injury in a human subject comprising:
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a device having reagents at each of a plurality of discrete locations, each reagent and corresponding location configured and arranged to immobilize for detection one of said plurality of subject-derived markers, supports the analysis of both (1) cellular fibronectin and (2) additional markers; and
a computer algorithm, residing on a computer, calculating in consideration of analyzed cellular fibronectin and additional markers a probability of present or future risk of cerebral injury for the subject. - View Dependent Claims (22, 23, 24)
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25. A method of determining presence or risk of cerebral injury in a human subject comprising:
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determining a presence or amount of cellular fibronectin in a human subject; and
predicting the risk of cerebral injury following thrombolyic therapy in accordance with the determined presence or amount. - View Dependent Claims (26, 27, 28)
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Specification