Clinical trial NCT06462599: Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Official title: Association of Osteopontin Gene Polymorphisms With Susceptibility and Prognosis of Ischemic Stroke in Egyptian Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Measure osteopontin level in ischaemic stroke patients and different gene polymorphisms related to the disease
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Researcher
name: Michel Effat, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Meseguer 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.
citation: Zhang 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.