Skip to content

Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients

Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07235423
Enrollment
120
Registered
2025-11-19
Start date
2025-12-01
Completion date
2028-01-15
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke, Acute

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

1. Adults (≥18 years). 2. Acute ischemic stroke due to anterior circulation LVO confirmed by imaging undergoing EVT per guidelines. 3. Successful reperfusion (mTICI 2b-3) 4. Able to provide consent.

Exclusion criteria

1. Severe aphasia/coma interfering with cognitive assessment. 2. Pre-existing dementia ( using Arabic version of the Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly). 3. Non-ischemic etiology. 4. Death within 72 hours. 5. Refusal to participate in the study.

Design outcomes

Primary

MeasureTime frameDescription
Cognitive impairment after thrombectomy (MoCA)3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomyCognitive 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.

Secondary

MeasureTime frameDescription
Depression and anxiety symptoms (HADS)3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomyPsychological status will be measured using the Hospital Anxiety and Depression Scale (HADS, score range 0-21 per subscale). Outcomes will include mean scores and prevalence of clinically significant symptoms.
Functional independence (Barthel Index)3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomyFunctional status will be assessed using the Barthel Index (score range 0-100). Higher scores indicate greater independence in activities of daily living.
Global disability (modified Rankin Scale)3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomyGlobal disability will be measured using the modified Rankin Scale (mRS, score range 0-6, with 0 indicating no symptoms and 6 indicating death).
Infarct volume (DWI MRI)Within 24-72 hours post-thrombectomyInfarct size will be quantified using diffusion-weighted MRI, measured in milliliters.
Domain-specific cognitive performance (OCS)3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomyFor participants scoring \<26 on MoCA, the Oxford Cognitive Screen (OCS) will be administered to evaluate specific domains of cognition (attention, executive function, memory, language, visuospatial ability).
CRPWithin 24-72 hours post-thrombectomyC-reactive protein (CRP, mg/L)
Lipid profileWithin 24-72 hours post-thrombectomylipid profile (mg/dL)
DdimerWithin 24-72 hours post-thrombectomyD-dimer (µg/mL)
White matter hyperintensity (Fazekas score)Within 24-72 hours post-thrombectomyWhite matter disease burden will be assessed using the Fazekas score (0-3 scale) on FLAIR MRI

Contacts

Primary ContactMohammad Ahmad Korayem
Mohammadkorayem@aun.edu.eg+201021478054

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026