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

NCT ID: NCT07235423

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-01-15

Brief Summary

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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

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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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Postthrombectomy

All patients wgo underwent endovascular thrombectomy under standard care will be assessed for cognitive function at 3 time points

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Ahmad Mohammad Korayem

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mohammad Ahmad Korayem

Role: CONTACT

+201021478054

Related Links

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Other Identifiers

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CogEVT25

Identifier Type: -

Identifier Source: org_study_id

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