Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients
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Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Ischemic Stroke, Acute. Базовые параметры: от 18 лет · Все.
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Официальное название
Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study
Обзор
This prospective cohort study investigates predictors of post-stroke cognitive impairment (PSCI) in patients undergoing endovascular thrombectomy (EVT) for acute ischemic stroke due to large vessel occlusion. Adult patients with successful reperfusion (mTICI 2b-3) will be followed at 3 and 6 months to assess cognition, functional recovery, and depression. Predictors across clinical, procedural, radiological, and laboratory domains will be analyzed. The study aims to identify risk factors for PSCI, estimate its prevalence, and evaluate its impact on outcomes.
Подробное описание
Post-stroke cognitive impairment (PSCI) is a major cause of long-term disability, affecting up to 40% of ischemic stroke survivors. Large vessel occlusion (LVO) strokes, often treated with endovascular thrombectomy (EVT), carry a particularly high risk of cognitive sequelae. While EVT has proven efficacy in improving functional outcomes, its effect on cognitive outcomes remains underexplored.
This prospective observational cohort study will enroll approximately 120 adult patients (≥18 years) with anterior circulation LVO undergoing EVT at Assiut University Hospital. Eligible participants must achieve successful reperfusion (mTICI 2b-3) and provide consent. Patients with severe aphasia, coma, pre-existing dementia, non-ischemic etiologies, or early death (within 72 hours) will be excluded.
Participants will undergo systematic assessment of cognitive function (MoCA-Arabic, Oxford Cognitive Screening if MoCA \<26), functional status (mRS, Barthel Index), and mood (HADS-Arabic) at baseline, 3 months, and 6 months. Clinical data (demographics, vascular risk factors, NIHSS, time metrics), procedural details (technique, procedure time, number of passes, anesthesia type, hemodynamic stability, complications), radiological parameters (infarct site and volume, ASPECTS, WMH by Fazekas score, cortical atrophy, microbleeds), and laboratory markers (CRP, ESR, lipid profile, HbA1C, uric acid, D-dimer, CBC) will be collected.
The primary objective is to identify predictors of PSCI at 3-6 months after thrombectomy. Secondary objectives include estimating the prevalence of PSCI in this population and analyzing its association with functional outcomes and depression. Statistical analysis will include univariate and multivariate regression models adjusting for potential confounders such as age, education, and infarct volume.
Ethical approval has been obtained from the Faculty of Medicine, Assiut University Ethics Committee. Written informed consent will be obtained from all participants, and confidentiality will be strictly maintained.
Первичные конечные точки
- Cognitive impairment after thrombectomy (MoCA) [Срок оценки: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
Вторичные конечные точки (9)
- Domain-specific cognitive performance (OCS) [Срок оценки: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
- Depression and anxiety symptoms (HADS) [Срок оценки: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
- Functional independence (Barthel Index) [Срок оценки: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
- Global disability (modified Rankin Scale) [Срок оценки: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
- Infarct volume (DWI MRI) [Срок оценки: Within 24-72 hours post-thrombectomy]
- White matter hyperintensity (Fazekas score) [Срок оценки: Within 24-72 hours post-thrombectomy]
- CRP [Срок оценки: Within 24-72 hours post-thrombectomy]
- Lipid profile [Срок оценки: Within 24-72 hours post-thrombectomy]
- Ddimer [Срок оценки: Within 24-72 hours post-thrombectomy]
Критерии участия
Критерии включения
- Adults (≥18 years).
- Acute ischemic stroke due to anterior circulation LVO confirmed by imaging undergoing EVT per guidelines.
- Successful reperfusion (mTICI 2b-3)
- Able to provide consent.
Критерии исключения
- Severe aphasia/coma interfering with cognitive assessment.
- Pre-existing dementia ( using Arabic version of the Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly).
- Non-ischemic etiology.
- Death within 72 hours.
- Refusal to participate in the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07235423 · CogEVT25