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Not yet recruiting NCT07235423

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

Observational Ischemic Stroke, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Ischemic Stroke, Acute. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Cognitive impairment after thrombectomy (MoCA) [Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
Secondary outcome measures (9)
  • Domain-specific cognitive performance (OCS) [Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
  • Depression and anxiety symptoms (HADS) [Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
  • Functional independence (Barthel Index) [Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
  • Global disability (modified Rankin Scale) [Time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy]
  • Infarct volume (DWI MRI) [Time frame: Within 24-72 hours post-thrombectomy]
  • White matter hyperintensity (Fazekas score) [Time frame: Within 24-72 hours post-thrombectomy]
  • CRP [Time frame: Within 24-72 hours post-thrombectomy]
  • Lipid profile [Time frame: Within 24-72 hours post-thrombectomy]
  • Ddimer [Time frame: Within 24-72 hours post-thrombectomy]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07235423 · CogEVT25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗