NCT04235920

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
Last Updated

June 23, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

January 17, 2020

Last Update Submit

June 20, 2020

Conditions

Keywords

Stroke; ASPEACTS, Modified Rankin Scale, National Institutes of Health Stroke Scale. Higher cortical functions, Biomarkers of cognitive impairment.

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment

    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.

    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

Study Arms (2)

Impaired Cognition

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

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Preserved cognition

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

Diagnostic Test: Montreal Cognitive Assessment (MoCA)

Interventions

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

Impaired CognitionPreserved cognition

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 28487329BACKGROUND
  • 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.

    PMID: 29632511BACKGROUND
  • 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.

    PMID: 25316278BACKGROUND
  • 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.

    PMID: 25147113BACKGROUND
  • 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.

MeSH Terms

Conditions

Ischemic StrokeCognitive DysfunctionStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 22, 2020

Study Start

October 1, 2017

Primary Completion

January 31, 2019

Study Completion

March 31, 2019

Last Updated

June 23, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations