Osteopontin Gene Polymorphism in Stroke Patients in Egypt

June 14, 2024 updated by: Madonna Nabil, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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:

    1. both sex
    2. Age between 18 to 70 years old.
    3. Duration of3to 6 month of development of ischemic symptoms

  • For control cases:

    1. both sex
    2. Healthy people

    3. Age: above 18 years old

      Exclusion Criteria:

      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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control
Healthy individuals
Genetic: Gene polymorphism from blood samples

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
Cases
Patients with ischaemic stroke
Genetic: Gene polymorphism from blood samples

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Michel Effat, Lecturer, Researcher

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

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

June 12, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gene polymorphisms in stroke

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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