Ischemic Stroke, AcuteNCT07235423
Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients
An observational study of Ischemic Stroke, Acute, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 15 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: As described in inclusion/exclusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postthrombectomy | All patients wgo underwent endovascular thrombectomy under standard care will be assessed for cognitive function at 3 time points |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Secondary outcomes (9)
Domain-specific cognitive performance (OCS)
For 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).
Measured: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Depression and anxiety symptoms (HADS)
Psychological 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.
Measured: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Functional independence (Barthel Index)
Functional status will be assessed using the Barthel Index (score range 0-100). Higher scores indicate greater independence in activities of daily living.
Measured: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Global disability (modified Rankin Scale)
Global disability will be measured using the modified Rankin Scale (mRS, score range 0-6, with 0 indicating no symptoms and 6 indicating death).
Measured: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy
Infarct volume (DWI MRI)
Infarct size will be quantified using diffusion-weighted MRI, measured in milliliters.
Measured: Within 24-72 hours post-thrombectomy
White matter hyperintensity (Fazekas score)
White matter disease burden will be assessed using the Fazekas score (0-3 scale) on FLAIR MRI
Measured: Within 24-72 hours post-thrombectomy
CRP
C-reactive protein (CRP, mg/L)
Measured: Within 24-72 hours post-thrombectomy
Lipid profile
lipid profile (mg/dL)
Measured: Within 24-72 hours post-thrombectomy
Ddimer
D-dimer (µg/mL)
Measured: Within 24-72 hours post-thrombectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ahmad Mohammad Korayem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07235423
- Sponsor's protocol ID
- CogEVT25
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Post-Thrombectomy Cognitive Impairment in Acute Ischemic Stroke Patients : a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07235423
- Acronym / sponsor ID
- CogEVT25
- Conditions
- Ischemic Stroke, Acute
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postthrombectomy | – | –All patients wgo underwent endovascular thrombectomy under standard care will be assessed for cognitive function at 3 time points |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- As described in inclusion/exclusion criteria
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive impairment after thrombectomy (MoCA)
Time frame: 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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Ahmad Korayem (+201021478054, Mohammadkorayem@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive impairment after thrombectomy (MoCA) (time frame: 3 months (±2 weeks) and 6 months (±2 weeks) post-thrombectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.