- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Undersøgelsestype
Tilmelding (Anslået)
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
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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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of Early Post-Stroke Cognitive Impairment (PSCI)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Biomarkers in Post-Stroke CI
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