- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07837466
Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
Role of Immune-Inflammatory Biomarkers in Predicting Early Cognitive Impairment in Adults With Acute Basal Ganglionic Stroke
Post-stroke cognitive impairment (PSCI) is a common and disabling complication that affects memory, thinking, and daily functioning after a stroke. The immune-inflammatory response triggered during an acute stroke is believed to contribute to secondary brain injury and cognitive decline. Routine, low-cost blood tests that assess systemic inflammation, specifically the neutrophil-to-lymphocyte ratio (NLR), globulin-to-lymphocyte ratio (GLR), C-reactive protein-to-lymphocyte ratio (CLR), and lymphocyte-to-monocyte ratio (LMR), may serve as useful early indicators of cognitive risk.
The purpose of this observational study is to evaluate whether these inflammatory blood markers, measured during the acute hospital phase, can independently predict early-onset cognitive impairment in adult patients aged 18 to 59 years with acute basal ganglionic stroke (ischemic or primary hemorrhagic).
Participants admitted within 72 hours of symptom onset will undergo standard clinical assessments, stroke severity evaluation using the National Institutes of Health Stroke Scale (NIHSS), brain neuroimaging (CT or MRI), and routine blood testing between 24 and 72 hours post-admission. At 3 months post-stroke, participants will complete a cognitive evaluation using the Arabic-validated Montreal Cognitive Assessment (MoCA). Identifying accessible admission biomarkers could help healthcare providers recognize patients at high risk of cognitive impairment early, enabling timely monitoring and early referral for cognitive rehabilitation.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Adult patients aged 18 to 59 years presenting with a confirmed first-ever acute stroke (ischemic or primary intracerebral hemorrhage) with basal ganglionic involvement, admitted to the Stroke Unit of the Department of Neurology at Assiut University Hospitals within 72 hours of symptom onset.
Opis
Inclusion Criteria:
- Age between 18 and 59 years.
- First-ever acute stroke (ischemic or primary intracerebral hemorrhage) confirmed by brain CT or MRI, with documented basal ganglionic involvement.
- Hospital admission within 72 hours of symptom onset.
- Written informed consent provided by the patient or their legally authorized representative.
Exclusion Criteria:
- Pre-existing cognitive impairment or dementia (e.g., Alzheimer's disease, vascular dementia).
- Severe neurological or sensory deficits precluding cognitive assessment, including severe aphasia, altered level of consciousness, or significant visual or hearing impairment.
- Severe organ dysfunction, including severe cardiac, hepatic, or renal insufficiency.
- Medical conditions confounding systemic inflammatory markers, including active systemic infection, autoimmune disease, or recent major surgery/trauma.
- Current or recent treatment with immunosuppressive drugs, systemic corticosteroids, or high-dose antibiotics.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
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Adults with Acute Basal Ganglionic Stroke
Adult patients aged 18 to 59 years presenting with a first-ever acute ischemic or primary hemorrhagic stroke involving the basal ganglia (confirmed by brain CT or MRI) and admitted within 72 hours of symptom onset. Participants undergo baseline neurological assessment, stroke severity scoring via the National Institutes of Health Stroke Scale (NIHSS), and venous blood sampling between 24 and 72 hours post-admission to evaluate circulating immune-inflammatory biomarkers (neutrophil-to-lymphocyte ratio [NLR], globulin-to-lymphocyte ratio [GLR], CRP-to-lymphocyte ratio [CLR], and lymphocyte-to-monocyte ratio [LMR]). Cognitive function is evaluated at 3 months post-stroke using the Arabic-validated Montreal Cognitive Assessment (MoCA) to determine the occurrence of post-stroke cognitive impairment. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence of Early Post-Stroke Cognitive Impairment (PSCI)
Ramy czasowe: 3 months post-stroke
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Post-stroke cognitive impairment is determined using the Arabic-validated Montreal Cognitive Assessment (MoCA). The MoCA tests multiple cognitive domains (visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation), yielding a total score between 0 and 30, where higher scores indicate better cognitive performance. Early PSCI is defined as an education-adjusted MoCA score of less than 23 (<23). |
3 months post-stroke
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- Biomarkers in Post-Stroke CI
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