Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cognitive Impairment and Outcome of Acute Ischemic Stroke.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04235920
Recruitment Status : Completed
First Posted : January 22, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Esmael, 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.

Condition or disease Intervention/treatment
Ischemic Stroke Cognitive Impairment Outcome, Fatal 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.

Layout table for study information
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 : October 1, 2017
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : March 31, 2019

Group/Cohort 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




Primary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235920


Locations
Layout table for location information
Egypt
Mansoura University Hospital
Mansoura, Dakahlia, Egypt, 35516
Sponsors and Collaborators
Mansoura University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Esmael M Ahmed, MD Assistant Prof of Neurology
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ahmed Esmael, Assistant Prof of Neurology, Mansoura University Hospital
ClinicalTrials.gov Identifier: NCT04235920    
Other Study ID Numbers: Mansoura University 12
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ahmed Esmael, Mansoura University Hospital:
Stroke; ASPEACTS, Modified Rankin Scale, National Institutes of Health Stroke Scale. Higher cortical functions, Biomarkers of cognitive impairment.
Additional relevant MeSH terms:
Layout table for MeSH terms
Stroke
Cerebral Infarction
Ischemia
Cognitive Dysfunction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Infarction
Brain Ischemia