NCT06462599

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2024

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

June 17, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

June 12, 2024

Last Update Submit

June 14, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline

Study Arms (2)

Cases

Patients with ischaemic stroke

Genetic: Gene polymorphism from blood samples

Control

Healthy individuals

Genetic: Gene polymorphism from blood samples

Interventions

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

CasesControl

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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\>)
  • 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.
  • Duration of3to 6 month of development of ischemic symptoms
  • For control cases:
  • both sex
  • Healthy people
  • Age: above 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 24355932BACKGROUND
  • 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.

    PMID: 33322093BACKGROUND
  • 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.

    PMID: 38544995BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Michel Effat, Lecturer

    Researcher

    STUDY DIRECTOR

Central Study Contacts

Madonna Nabil, Demonstrator

CONTACT

Thoraya Eldeeb, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 17, 2024

Study Start

September 1, 2024

Primary Completion

September 1, 2024

Study Completion

October 1, 2025

Last Updated

June 17, 2024

Record last verified: 2024-06