Ischemic StrokeNCT04235920
Cognitive Impairment and Outcome of Acute Ischemic Stroke.
An observational study of Ischemic Stroke and Cognitive Impairment, run by Mansoura University Hospital at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Cognitive Impairment, Outcome, Fatal
- What is being tested?
- Montreal Cognitive Assessment (MoCA)
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2017to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- First attack of acute MCA territory infarction within 2 days from the onset.
Who cannot join
- previous stroke,
- presence of anterior cerebral artery infarction,
- posterior cerebral artery infarction, and
- venous infarction.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: 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.
Read the 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.
- Conditions
- Ischemic Stroke, Cognitive Impairment, Outcome, Fatal
- Being tested
- Montreal Cognitive Assessment (MoCA)
- Keywords
- Stroke; ASPEACTS, Modified Rankin Scale, National Institutes of Health Stroke Scale. Higher cortical functions, Biomarkers of cognitive impairment.
- Medical subject headings
- Ischemic Stroke, Cognitive Dysfunction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Montreal Cognitive Assessment (MoCA)Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| Impaired Cognition | First group was cognitively impaired test with MoCA score of 25 or less. Receives: Diagnostic Test: Montreal Cognitive Assessment (MoCA) | |
| Preserved cognition | The second group was cognitively preserved with MoCA score of higher than 25. Receives: Diagnostic Test: Montreal Cognitive Assessment (MoCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start1 Oct 2017
- Primary completion31 Jan 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04235920
- Sponsor's protocol ID
- Mansoura University 12
- Status last verified
- Jun 2020
- First submitted
- 17 Jan 2020
- Last updated
- 23 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28487329Taylor-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.
PubMed 29632511Schroder 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.
PubMed 25316278Tan 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.
PubMed 25147113Esmael 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.
PubMed 33575025
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Alberta Stroke Program Early CT Score (ASPECTS) With Cognitive Impairment and Outcome of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT04235920
- Acronym / sponsor ID
- Mansoura University 12
- Conditions
- Ischemic Stroke, Cognitive Impairment, Outcome, Fatal
- Keywords
- Stroke; ASPEACTS, Modified Rankin Scale, National Institutes of Health Stroke Scale. Higher cortical functions, Biomarkers of cognitive impairment.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Impaired Cognition | – | Diagnostic Test: Montreal Cognitive Assessment (MoCA)First group was cognitively impaired test with MoCA score of 25 or less. |
| Preserved cognition | – | Diagnostic Test: Montreal Cognitive Assessment (MoCA)The second group was cognitively preserved with MoCA score of higher than 25. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- First attack of acute MCA territory infarction within 2 days from the onset.
Key exclusion criteria (4 listed)
- previous stroke,
- presence of anterior cerebral artery infarction,
- posterior cerebral artery infarction, and
- venous infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Diagnostic test | Impaired Cognition, Preserved cognition |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2020.
- Background: PubMed 28487329Mokin 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.
- Background: PubMed 29632511Taylor-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.
- Background: PubMed 25316278Schroder 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.
- Background: PubMed 25147113Tan 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.
- Derived from this study: PubMed 33575025Esmael 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke and Cognitive Impairment, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: 3 month after discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04235920, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2020.