Ischemic StrokeNCT06462599
Osteopontin Gene Polymorphism in Stroke Patients in Egypt
An observational study of Ischemic Stroke, run by Assiut University.
Trial summary
This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Gene polymorphism from blood samples
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Oct 2025
- 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 to 70 years
- All sexes
- Adult, Older adult
Study population: we will enrol 72 participants; 36 stroke patients and 36 control cases (age matched) recruited among the attendants of Neurology department, Assiut University Hospital, adult age.
Who may be able to join
- For acute ischemic stroke cases:
- ( Acute ischemic stroke will be defined as an episode of focal neurological deficits lasting for more than 24 hour with relevant lesion in brain computerized tomography (CT) or magnetic resonance (MR) image>)
- 1- both sex 2- Age between 18 to 70 years old. 3-symptoms suggestive of acute ischemic stroke: presenting within 24 hours of onset of these symptoms
- For old ischemic stroke:
- both sex
- Age between 18 to 70 years old.
Show all 11Show fewer
- Duration of3to 6 month of development of ischemic symptoms
- For control cases:
- both sex
- Healthy people
- Age: above 18 years old
Who cannot join
- Patients with a previous history of stroke; Patients with hemorrhagic stroke. Patients with coronary heart disease, heart failure, chronic inflammation, intracranial infection/brain tumor and malignant tumor.
- Patients with liver, kidney and other important organ dysfunction. Patients with severe abnormal coagulation function
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Association of Osteopontin Gene Polymorphisms With Susceptibility and Prognosis of Ischemic Stroke in Egyptian Patients
This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients
Read the detailed description
The Global Burden of Disease estimated that one person in four aged 25 years will have a stroke in the rest of her/his life. Among them, ischemic stroke (IS) represents 80%.
Stroke is accompanied by a neuroinflammatory response involving immune system. These long-term processes following IS are still far from being understood. So, despite the significant improvement in the diagnosis and treatment of IS, the disability and mortality rate of IS are still rising. An assessment of the prognostic risk of IS should be carried out as early as possible and corresponding interventions should be adopted clinically, in order to have a significant impact on the prognosis of patients with IS.
Predicting the outcome in individual patients solely based on clinical and radiological parameters is challenging for clinicians. Measuring blood biomarkers associated with inflammation, endothelial function, matrix remodeling, and immune functions, may improve prediction performance .
Osteopontin (OPN) is a matricellular protein participating in many physiological and pathologic processes including wound healing, bone turnover, tumor genesis, inflammation, and immune responses . It is well accepted that OPN is an important mediator in stroke pathophysiology. OPN expression is upregulated in microglia surrounding the infarcted area and in microglia and infiltrating macrophages in the infarct area. OPN and microglia seems to exhibit an intimate relationship in stroke with rather beneficial functions for the clinical outcome. However, the role of OPN in stroke-related diseases as atherosclerosis and diabetes should be further disentangled as in this early phase of disease OPN may ultimately culminate in cerebrovascular dysfunction. OPN may exert opposing effects and should be therefore addressed differently.
- Conditions
- Ischemic Stroke
- Being tested
- Gene polymorphism from blood samples
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gene polymorphism from blood samplesGenetic
Blood samples will be collected from stroke patients within 24 hrs of stroke and normal volunteers.
Two samples will be collected serum and plasma; five ml whole blood from patients and normal volunteers and centrifuge serum samples at 1500 rpm 10 min then will be stored at - 80 °C until the day of the analysis.
Plasma samples will be stored at - 80 °C until the day of the analysis without centrifugation
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with ischaemic stroke Receives: Genetic: Gene polymorphism from blood samples | |
| Control | Healthy individuals Receives: Genetic: Gene polymorphism from blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease
investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients.
Correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madonna Nabil, Assiut University
- Investigators
- Michel Effat, Lecturer, Study director, Researcher
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462599
- Sponsor's protocol ID
- Gene polymorphisms in stroke
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jing M, Li B, Hou X, Shoba J, Li C, Liang H, Zhang X, Liu E, Yang B, Meng X. OPN gene polymorphism and the serum OPN levels confer the susceptibility and prognosis of ischemic stroke in Chinese patients. Cell Physiol Biochem. 2013;32(6):1798-807. doi: 10.1159/000356613. Epub 2013 Dec 13.
PubMed 24355932Meseguer E, Diallo D, Labreuche J, Charles H, Delbosc S, Mangin G, Monteiro Tavares L, Caligiuri G, Nicoletti A, Amarenco P. Osteopontin Predicts Three-Month Outcome in Stroke Patients Treated by Reperfusion Therapies. J Clin Med. 2020 Dec 13;9(12):4028. doi: 10.3390/jcm9124028.
PubMed 33322093Zhang Y, Wang JR, Zhang EN, Zhao ZJ. Analysis of the effect of changes in serum osteopontin levels on patients with acute cerebral infarction. Pak J Med Sci. 2024 Mar-Apr;40(4):718-722. doi: 10.12669/pjms.40.4.7045.
PubMed 38544995
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Osteopontin Gene Polymorphisms With Susceptibility and Prognosis of Ischemic Stroke in Egyptian Patients
- ClinicalTrials.gov ID
- NCT06462599
- Acronym / sponsor ID
- Gene polymorphisms in stroke
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 17 Jun 2024 (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.
This study aims to investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients and correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients
Detailed description
The Global Burden of Disease estimated that one person in four aged 25 years will have a stroke in the rest of her/his life. Among them, ischemic stroke (IS) represents 80%.
Stroke is accompanied by a neuroinflammatory response involving immune system. These long-term processes following IS are still far from being understood. So, despite the significant improvement in the diagnosis and treatment of IS, the disability and mortality rate of IS are still rising. An assessment of the prognostic risk of IS should be carried out as early as possible and corresponding interventions should be adopted clinically, in order to have a significant impact on the prognosis of patients with IS.
Predicting the outcome in individual patients solely based on clinical and radiological parameters is challenging for clinicians. Measuring blood biomarkers associated with inflammation, endothelial function, matrix remodeling, and immune functions, may improve prediction performance .
Osteopontin (OPN) is a matricellular protein participating in many physiological and pathologic processes including wound healing, bone turnover, tumor genesis, inflammation, and immune responses . It is well accepted that OPN is an important mediator in stroke pathophysiology. OPN expression is upregulated in microglia surrounding the infarcted area and in microglia and infiltrating macrophages in the infarct area. OPN and microglia seems to exhibit an intimate relationship in stroke with rather beneficial functions for the clinical outcome. However, the role of OPN in stroke-related diseases as atherosclerosis and diabetes should be further disentangled as in this early phase of disease OPN may ultimately culminate in cerebrovascular dysfunction. OPN may exert opposing effects and should be therefore addressed differently.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: Gene polymorphism from blood samplesPatients with ischaemic stroke |
| Control | – | Genetic: Gene polymorphism from blood samplesHealthy individuals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- we will enrol 72 participants; 36 stroke patients and 36 control cases (age matched) recruited among the attendants of Neurology department, Assiut University Hospital, adult age.
Key inclusion criteria (11 listed)
- For acute ischemic stroke cases:
- ( Acute ischemic stroke will be defined as an episode of focal neurological deficits lasting for more than 24 hour with relevant lesion in brain computerized tomography (CT) or magnetic resonance (MR) image>)
- 1- both sex 2- Age between 18 to 70 years old. 3-symptoms suggestive of acute ischemic stroke: presenting within 24 hours of onset of these symptoms
- For old ischemic stroke:
- For control cases:
Key exclusion criteria (2 listed)
- Patients with a previous history of stroke; Patients with hemorrhagic stroke. Patients with coronary heart disease, heart failure, chronic inflammation, intracranial infection/brain tumor and malignant tumor.
- Patients with liver, kidney and other important organ dysfunction. Patients with severe abnormal coagulation function
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 |
|---|---|---|
| Gene polymorphism from blood samplesBlood samples will be collected from stroke patients within 24 hrs of stroke and normal volunteers. Two samples will be collected serum and plasma; five ml whole blood from patients and normal volunteers and centrifuge serum samples at 1500 rpm 10 min then will be stored at - 80 °C until the day of the analysis. Plasma samples will be stored at - 80 °C until the day of the analysis without centrifugation | Genetic | Cases, Control |
Primary outcome
Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease
Time frame: Baseline
investigate the correlation of serum osteopontin level as a predictior and a prognostic factor in upper egyptian patients. Correlation between Osteopontin Gene Polymorphisms and serum level of osteopontin in ischaemic stroke patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Background: PubMed 24355932Jing M, Li B, Hou X, Shoba J, Li C, Liang H, Zhang X, Liu E, Yang B, Meng X. OPN gene polymorphism and the serum OPN levels confer the susceptibility and prognosis of ischemic stroke in Chinese patients. Cell Physiol Biochem. 2013;32(6):1798-807. doi: 10.1159/000356613. Epub 2013 Dec 13.
- Background: PubMed 33322093Meseguer E, Diallo D, Labreuche J, Charles H, Delbosc S, Mangin G, Monteiro Tavares L, Caligiuri G, Nicoletti A, Amarenco P. Osteopontin Predicts Three-Month Outcome in Stroke Patients Treated by Reperfusion Therapies. J Clin Med. 2020 Dec 13;9(12):4028. doi: 10.3390/jcm9124028.
- Background: PubMed 38544995Zhang Y, Wang JR, Zhang EN, Zhao ZJ. Analysis of the effect of changes in serum osteopontin levels on patients with acute cerebral infarction. Pak J Med Sci. 2024 Mar-Apr;40(4):718-722. doi: 10.12669/pjms.40.4.7045.
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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.
Michel Effat, Lecturer study director
Researcher
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Assiut University.
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 11 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Madonna Nabil, Demonstrator (01285958827, nabilmagy69@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease (time frame: Baseline). 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 NCT06462599, which also lists 3 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 17 Jun 2024; AzTrials last refreshed its copy on 6 Nov 2026.