- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04235920
Cognitive Impairment and Outcome of Acute Ischemic Stroke.
June 20, 2020 updated by: Ahmed Esmael, Mansoura University Hospital
Correlation of Alberta Stroke Program Early CT Score (ASPECTS) With Cognitive Impairment and Outcome of Acute Ischemic Stroke
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Dakahlia
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Mansoura, Dakahlia, Egypt, 35516
- Mansoura University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
79 males and 71 females with a mean age of 64.05 ±11.55 were included in this study and were admitted with the first attack of acute MCA territory infarction within 2 days from the onset and aged more than 18 years.
Acute ischemic stroke (AIS) was defined as a rapidly developing neurological deficit with an obvious known onset, and an initial CT brain with no proof of ICH.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Impaired Cognition
First group was cognitively impaired test with MoCA score of 25 or less.
|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Montreal Cognitive Assessment
Time Frame: 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
|
3 month after discharge
|
Assessment of CT brain was done by ASPECTS.
Time Frame: 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
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Mokin M, Primiani CT, Siddiqui AH, Turk AS. ASPECTS (Alberta Stroke Program Early CT Score) Measurement Using Hounsfield Unit Values When Selecting Patients for Stroke Thrombectomy. Stroke. 2017 Jun;48(6):1574-1579. doi: 10.1161/STROKEAHA.117.016745. Epub 2017 May 9.
- Taylor-Rowan M, Wilson A, Dawson J, Quinn TJ. Functional Assessment for Acute Stroke Trials: Properties, Analysis, and Application. Front Neurol. 2018 Mar 26;9:191. doi: 10.3389/fneur.2018.00191. eCollection 2018.
- Schroder J, Cheng B, Ebinger M, Kohrmann M, Wu O, Kang DW, Liebeskind DS, Tourdias T, Singer OC, Christensen S, Campbell B, Luby M, Warach S, Fiehler J, Fiebach JB, Gerloff C, Thomalla G; STIR and VISTA Imaging Investigators. Validity of acute stroke lesion volume estimation by diffusion-weighted imaging-Alberta Stroke Program Early Computed Tomographic Score depends on lesion location in 496 patients with middle cerebral artery stroke. Stroke. 2014 Dec;45(12):3583-8. doi: 10.1161/STROKEAHA.114.006694. Epub 2014 Oct 14.
- Tan JP, Li N, Gao J, Wang LN, Zhao YM, Yu BC, Du W, Zhang WJ, Cui LQ, Wang QS, Li JJ, Yang JS, Yu JM, Xia XN, Zhou PY. Optimal cutoff scores for dementia and mild cognitive impairment of the Montreal Cognitive Assessment among elderly and oldest-old Chinese population. J Alzheimers Dis. 2015;43(4):1403-12. doi: 10.3233/JAD-141278.
- Esmael A, Elsherief M, Eltoukhy K. Predictive Value of the Alberta Stroke Program Early CT Score (ASPECTS) in the Outcome of the Acute Ischemic Stroke and Its Correlation with Stroke Subtypes, NIHSS, and Cognitive Impairment. Stroke Res Treat. 2021 Jan 29;2021:5935170. doi: 10.1155/2021/5935170. eCollection 2021.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2017
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
March 31, 2019
Study Registration Dates
First Submitted
January 17, 2020
First Submitted That Met QC Criteria
January 17, 2020
First Posted (Actual)
January 22, 2020
Study Record Updates
Last Update Posted (Actual)
June 23, 2020
Last Update Submitted That Met QC Criteria
June 20, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurocognitive Disorders
- Brain Ischemia
- Cognition Disorders
- Infarction
- Brain Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Cognitive Dysfunction
- Cerebral Infarction
Other Study ID Numbers
- Mansoura University 12
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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