Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- Cognitive impairment after thrombectomy (MoCA)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Cognitive impairment after thrombectomy (MoCA)
时间窗: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Cognitive status will be assessed using the Arabic version of the Montreal Cognitive Assessment (MoCA, score range 0-30, with scores \<26 indicating impairment). The primary outcome will be the prevalence of post-stroke cognitive impairment (PSCI) among thrombectomy patients.
次要结局
- Domain-specific cognitive performance (OCS)(3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy)
- Depression and anxiety symptoms (HADS)(3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy)
- Functional independence (Barthel Index)(3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy)
- Global disability (modified Rankin Scale)(3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy)
- Infarct volume (DWI MRI)(Within 24-72 hours post-thrombectomy)
- White matter hyperintensity (Fazekas score)(Within 24-72 hours post-thrombectomy)
- CRP(Within 24-72 hours post-thrombectomy)
- Lipid profile(Within 24-72 hours post-thrombectomy)
- Ddimer(Within 24-72 hours post-thrombectomy)
研究者
Mohammad Ahmad Mohammad Korayem
Assistant lecturer
Assiut University