Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in Ischemic Stroke

June 24, 2024 updated by: Asmaa Abdel-mageed Muhammed, Aswan University Hospital

Role of Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in the Pathophysiology of Ischemic Stroke in Human and Albino Rats

This observational study aims to detect levels of iron, alpha-synuclein, and soluble lymphocyte activation gene 3 in acute ischemic stroke patients. And to see expressions of iron, alpha-synuclein, and lymphocyte activation gene 3 in the brain tissue of ischemic rats. The main questions it aims to answer are:

  • Is there an association between iron and alpha-synuclein accumulation in ischemic stroke?
  • Is there any change in soluble lymphocyte activation gene levels in ischemic stroke and if these levels are related to stroke severity and infarction size? . Can soluble lymphocyte activation gene levels be used as an early biomarker to diagnose ischemic stroke?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

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

Study Locations

  • Egypt
      • Aswan, Egypt, 81528
        • Aswan University Hospital

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

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with neurological symptoms of acute ischemic stroke

Description

Inclusion Criteria:

  1. Patients at the age between 50-70 years.
  2. Patients having neurological symptoms of acute ischemic stroke.

Exclusion Criteria:

  1. Patients with acute hemorrhagic stroke.
  2. Patients with Parkinson's disease (PD).
  3. Patients with dementia, and Alzheimer's disease.
  4. Patients with any type of malignancy.
  5. Patients with central nervous system infection.

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
24 healthy age and sex-matched controls
Diagnostic test: Serum Iron
Serum iron levels in study groups
Diagnostic test: RBCs Alpha-synuclein
α-syn levels in RBCs
Other Names:
  • α-syn
Diagnostic test: Serum Soluble lymphocyte activation gene
sLAG-3 in the serum of study groups
Other Names:
  • sLAG-3
Radiation: Brain computed tomography
Brain CT of patients after admission
Other Names:
  • CT
Patients with acute Ischemic stroke

24 patients between 50-70 years having neurological symptoms of acute ischemic stroke will be included.

Patients with acute hemorrhagic stroke, Parkinson's disease, dementia, Alzheimer's disease, malignancy, and central nervous system infection will be excluded.
Diagnostic test: Serum Iron
Serum iron levels in study groups
Diagnostic test: RBCs Alpha-synuclein
α-syn levels in RBCs
Other Names:
  • α-syn
Diagnostic test: Serum Soluble lymphocyte activation gene
sLAG-3 in the serum of study groups
Other Names:
  • sLAG-3
Radiation: Brain computed tomography
Brain CT of patients after admission
Other Names:
  • CT
Control rats
8 rats will be subjected to a Sham operation and will be injected intramuscularly immediately after the operation with an equivalent 0.9% saline solution. After 24 hours they will be sacrificed.
Diagnostic test: Brain Iron
Iron in brain homogenate of rats
Diagnostic test: Brain Alpha-synuclein
α-syn expression in rat's brain
Other Names:
  • α-syn
Diagnostic test: Brain lymphocyte activation gene
LAG-3 expression in rat's brain
Other Names:
  • LAG-3
Rats with ischemic stroke
8 rats will be subjected to bilateral common carotid artery occlusion (CCAO) for 30 minutes and will be injected intramuscularly immediately after removing the occlusion with an equivalent 0.9% saline solution. They will be sacrificed after 24 hours of reperfusion.
Diagnostic test: Brain Iron
Iron in brain homogenate of rats
Diagnostic test: Brain Alpha-synuclein
α-syn expression in rat's brain
Other Names:
  • α-syn
Diagnostic test: Brain lymphocyte activation gene
LAG-3 expression in rat's brain
Other Names:
  • LAG-3
Rats with ischemic stroke + deferoxamine
8 rats will be subjected to bilateral CCAO for 30 minutes and will be injected intramuscularly immediately after removing the occlusion with deferoxamine (200 mg/kg), They will be sacrificed after 24 hours of reperfusion.
Diagnostic test: Brain Iron
Iron in brain homogenate of rats
Diagnostic test: Brain Alpha-synuclein
α-syn expression in rat's brain
Other Names:
  • α-syn
Diagnostic test: Brain lymphocyte activation gene
LAG-3 expression in rat's brain
Other Names:
  • LAG-3
Drug: Deferoxamine
intramuscular deferoxamine (200 mg/kg) injection to rats

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Iron levels
Time Frame: 6 months
Serum iron levels in ischemic patients and control
6 months
Alpha-synuclein levels
Time Frame: 6 months
Alpha-synuclein levels in RBCs in ischemic patients and control
6 months
levels of iron, alpha-synuclein, and soluble lymphocyte activation in relation to stroke severity and infarction size
Time Frame: 6 months
stroke severity will be evaluated by the National Institutes of Health Stroke Scale (NIHSS) and size of infarction will be detected by brain CT
6 months
Iron levels in brain of rats
Time Frame: 2 months
Iron levels in brain homogenate of rats in the three rat groups
2 months
Levels of Soluble lymphocyte activation gene-3
Time Frame: 6 months
Serum soluble lymphocyte activation gene-3 in ischemic patients and control
6 months
Levels of Alpha-synuclein expression in brain of rats
Time Frame: 2 months
Alpha-synuclein expression in brain of rats in different groups
2 months
Levels of Lymphocyte activation gene-3 expression in brain of rats
Time Frame: 2 months
lymphocyte activation gene-3 expression in brain of rats in different groups
2 months

Collaborators and Investigators

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

Sponsor

Aswan University Hospital

Investigators

  • Principal Investigator: Asmaa Abdelmageed Muhammed, Aswan University Hospital

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 (Actual)

April 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

April 1, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

February 28, 2023

Study Record Updates

Last Update Posted (Actual)

June 25, 2024

Last Update Submitted That Met QC Criteria

June 24, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • sLAG-3 in brain ischemia

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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