NCT07235423

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Dec 2025

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress20%
Dec 2025Jan 2028

First Submitted

Initial submission to the registry

September 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2027

Expected
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2028

Last Updated

November 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.1 years

First QC Date

September 19, 2025

Last Update Submit

November 17, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive impairment after thrombectomy (MoCA)

    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.

    3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy

Secondary Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

Postthrombectomy

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

As described in inclusion/exclusion criteria

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mohammad Ahmad Korayem

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

September 19, 2025

First Posted

November 19, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

December 30, 2027

Study Completion (Estimated)

January 15, 2028

Last Updated

November 19, 2025

Record last verified: 2025-09