GFAP accumulating in stroke
Inventors
Fitzgerald, Stephen Peter • McConnell, Ivan • Richardson, Ciaran • LaMont, John • Makris, Konstantinos
Assignees
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Publication Number
US-12332252-B2
Publication Date
2025-06-17
Expiration Date
Abstract
The disclosure describes the use of glial fibrillary acidic protein as a marker of pernicious stroke.
Core Innovation
The method relates to diagnosis and treatment of a suspected pernicious stroke patient admitted <6 hours from symptom onset by obtaining a first biological sample comprising blood, serum or plasma and measuring a first amount of glial fibrillary acidic protein (GFAP). A brain CT scan is performed on admission, and the patient is diagnosed as having fatal ischemic stroke or hemorrhagic transformation based on the measured GFAP level together with whether the CT scan is negative for hemorrhagic stroke.
Fatal ischemic stroke is identified when the first amount of GFAP is at least 2-fold higher than a normal control level, where the normal control level is defined as a population comprising non-fatal ischemic stroke patients or a value within a range of 0.140 ng/ml to 0.205 ng/ml, and when the CT scan is negative for hemorrhagic stroke. Non-fatal ischemic stroke undergoing hemorrhagic transformation is identified when the amount of GFAP in the first sample is the normal control level and the CT scan is negative for hemorrhagic stroke at admission.
The method further comprises measuring a second amount of GFAP in a further biological sample taken from the patient at 324 hours from admission or symptom onset, where a higher level of the second amount than the first level measured in patients identified as having fatal ischemic stroke is indicative of hemorrhagic transformation.
Based on the diagnosis, treatment is selected so that the therapy for fatal ischemic stroke comprises an anti-thrombolytic therapy and/or an anti-coagulative therapy, while the therapy for hemorrhagic transformation comprises administering surgical repair of a damaged blood vessel.
Claims Coverage
The document provides one independent claim that sets out a full diagnostic-and-treatment method, with additional dependent claims specifying refinements to the timing and quantitative ranges for GFAP measurements.
Timed GFAP measurement from admission blood, serum or plasma with CT on admission
Obtaining a first biological sample from a suspected pernicious stroke patient at admission, wherein the patient is admitted <6 hours from symptom onset, and wherein the biological sample is blood, serum or plasma; measuring a first amount of glial fibrillary acidic protein (GFAP); subjecting the patient to a brain CT scan on admission.
GFAP thresholding against defined normal control to classify fatal ischemic stroke versus hemorrhagic transformation
Diagnosing the patient as having fatal ischemic stroke or hemorrhagic transformation comprising: identifying the patient as having fatal ischemic stroke when the first amount of GFAP is at least 2-fold higher than a normal control level, wherein the normal control level is the level of GFAP measured in a population of patients comprising non-fatal ischemic stroke patients or a value within a range of 0.140 ng/ml to 0.205 ng/ml, and the CT scan is negative for hemorrhagic stroke; and identifying the patient as having non-fatal ischemic stroke undergoing hemorrhagic transformation when the amount of GFAP in the first sample has the normal control level and the CT scan is negative for hemorrhagic stroke at admission.
Second GFAP measurement at 324 hours to indicate hemorrhagic transformation
Measuring a second amount of GFAP in a further biological sample taken from said patient at 324 hours from admission or symptom onset, wherein a higher level of the second amount of GFAP in the second sample than the first level of GFAP measured in the patient identified as having fatal ischemic stroke is indicative of hemorrhagic transformation.
Diagnosis-guided therapy selection: anti-thrombolytic or anti-coagulative therapy versus surgical repair
Treating the diagnosed patient comprising administering a therapy, wherein the therapy for the identified patient of (i) is selected from the group consisting of an anti-thrombolytic therapy, anti-coagulative therapy or combination, and the therapy for the patient of (ii) comprises administering surgical repair of a damaged blood vessel.
Across the independent claim, the inventive concept is a diagnostic pathway that combines early GFAP measurement in blood, serum or plasma with an admission brain CT scan, uses GFAP compared to a defined normal control level to classify fatal ischemic stroke versus non-fatal ischemic stroke undergoing hemorrhagic transformation, incorporates a second GFAP measurement at 324 hours to indicate hemorrhagic transformation, and then selects treatment as anti-thrombolytic or anti-coagulative therapy, or combination, versus surgical repair.
Stated Advantages
Enables diagnosis of fatal ischemic stroke versus non-fatal ischemic stroke undergoing hemorrhagic transformation using GFAP measurement in blood, serum or plasma together with brain CT on admission.
Provides a decision basis for selecting treatment as anti-thrombolytic and/or anti-coagulative therapy for fatal ischemic stroke versus surgical repair of a damaged blood vessel for hemorrhagic transformation.
Documented Applications
Diagnosis and treatment of suspected pernicious stroke patients admitted <6 hours from symptom onset, including stratification into fatal ischemic stroke versus non-fatal ischemic stroke undergoing hemorrhagic transformation and corresponding therapy selection.
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