Cognitive Impairment and Outcome of Acute Ischemic Stroke.

Sponsor
Mansoura University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04235920
Collaborator
(none)
150
1
17.9
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Montreal Cognitive Assessment (MoCA)

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 Design

Study Type:
Observational
Actual Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Correlation of Alberta Stroke Program Early CT Score (ASPECTS) With Cognitive Impairment and Outcome of Acute Ischemic Stroke
Actual Study Start Date :
Oct 1, 2017
Actual Primary Completion Date :
Jan 31, 2019
Actual Study Completion Date :
Mar 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Impaired Cognition

First group was cognitively impaired test with MoCA score of 25 or less.

Diagnostic Test: Montreal Cognitive Assessment (MoCA)
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

Preserved cognition

The second group was cognitively preserved with MoCA score of higher than 25.

Diagnostic Test: Montreal Cognitive Assessment (MoCA)
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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mansoura University Hospital Mansoura Dakahlia Egypt 35516

Sponsors and Collaborators

  • Mansoura University Hospital

Investigators

  • Principal Investigator: Esmael M Ahmed, MD, Assistant Prof of Neurology

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
ClinicalTrials.gov Identifier:
NCT04235920
Other Study ID Numbers:
  • Mansoura University 12
First Posted:
Jan 22, 2020
Last Update Posted:
Jun 23, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 23, 2020