Cognitive Impairment and Outcome of Acute Ischemic Stroke.

Completed

• Conditions: Ischemic Stroke; Outcome, Fatal; Cognitive Impairment
• Interventions: Diagnostic Test: Montreal Cognitive Assessment (MoCA)

• Registration Number: NCT04235920
• Lead Sponsor: Mansoura University Hospital

Brief Summary

The aim of this study is to assess the use of ASPECTS and stroke biomarkers to predict the outcome and cognitive impairment in acute ischemic stroke.

Detailed Description

150 patients (79 males, and 71 females with a mean age of 64.05±11.55 years) were included in this study presented by acute middle cerebral artery territory ischemic stroke. Vascular risk factors were determined from the history taking. Assessment of GCS and NIHSS at the initial presentation was done to assess the stroke severity. Cognitive functions were evaluated in all study participants by the Montreal Cognitive Assessment (MoCA) Arabic version. An initial and follow up non-contrast CT brain was done after 7 days which were assessed by ASPECTS. Functional outcomes in stroke cases were assessed after three months by Glasgow Coma Scale, National Institutes of Health Stroke Scale and modified Rankin Scale. Biomarkers of cognitive impairment like ESR, CRP, S100B, MMP9 and glutamate were evaluated.

Study Timeline

• Study Start: 2017-10-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-03-31
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-17
• Study First Posted: 2020-01-22
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-20
• Last Update Posted: 2020-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• First attack of acute MCA territory infarction within 2 days from the onset.

Exclusion Criteria

• previous stroke,
• presence of anterior cerebral artery infarction,
• posterior cerebral artery infarction, and
• venous infarction.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preserved cognition	Montreal Cognitive Assessment (MoCA)	The second group was cognitively preserved with MoCA score of higher than 25.
Impaired Cognition	Montreal Cognitive Assessment (MoCA)	First group was cognitively impaired test with MoCA score of 25 or less.

Primary Outcome Measures

Name	Time	Method
Assessment of CT brain was done by ASPECTS.	7 days	The ASPECTS scoring was calculated for all patients. CT brain images were assessed for proof of localized parenchymal hypo-attenuation, loss of differentiation between gray and white matter, and if there is effacement of sulci. ASPECTS gives reliable methods for evaluation of ischemic stroke by utilizing a ten-point score "M1, M2, M3, M4, M5, M6, I: insula, IC: internal capsule, L: lentiform, and C: caudate" everyone represents one point. A Score of 10 means a normal CT scan. One point is decreased for each affected area on the CT brain. So, a score of 0 indicates widespread ischemia affecting the MCA territory
Montreal Cognitive Assessment	3 month after discharge	This scale evaluates different domains of cognition like attention, orientation, memory, language, visuoconstructional capacities, and lastly, executive functions. MoCA is a thirty point test with a score of 25 or less considered as abnormal impaired cognition

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt