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

Completed

• Conditions: Brain Ischemia
• Interventions: Diagnostic Test: Brain Iron; Diagnostic Test: Serum Iron; Diagnostic Test: RBCs Alpha-synuclein; Diagnostic Test: Brain Alpha-synuclein; Diagnostic Test: Brain lymphocyte activation gene; Diagnostic Test: Serum Soluble lymphocyte activation gene; Radiation: Brain computed tomography; Drug: Deferoxamine

• Registration Number: NCT05748587
• Lead Sponsor: Aswan University Hospital

Brief Summary

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?

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Study First Posted: 2023-02-28
• Study Start: 2023-04-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rats with ischemic stroke	Brain lymphocyte activation gene	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.
Rats with ischemic stroke + deferoxamine	Brain Iron	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.
Patients with acute Ischemic stroke	RBCs Alpha-synuclein	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.
Rats with ischemic stroke	Brain Alpha-synuclein	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.
Patients with acute Ischemic stroke	Serum Iron	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.
Control rats	Brain Alpha-synuclein	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.
Patients with acute Ischemic stroke	Brain computed tomography	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.
Control	Serum Iron	24 healthy age and sex-matched controls
Control	RBCs Alpha-synuclein	24 healthy age and sex-matched controls
Control	Serum Soluble lymphocyte activation gene	24 healthy age and sex-matched controls
Patients with acute Ischemic stroke	Serum Soluble lymphocyte activation gene	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.
Rats with ischemic stroke	Brain Iron	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.
Control	Brain computed tomography	24 healthy age and sex-matched controls
Control rats	Brain Iron	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.
Control rats	Brain lymphocyte activation gene	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.
Rats with ischemic stroke + deferoxamine	Brain lymphocyte activation gene	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.
Rats with ischemic stroke + deferoxamine	Brain Alpha-synuclein	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.
Rats with ischemic stroke + deferoxamine	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.

Primary Outcome Measures

Name	Time	Method
Alpha-synuclein levels	6 months	Alpha-synuclein levels in RBCs in ischemic patients and control
Levels of Soluble lymphocyte activation gene-3	6 months	Serum soluble lymphocyte activation gene-3 in ischemic patients and control
levels of iron, alpha-synuclein, and soluble lymphocyte activation in relation to stroke severity and infarction size	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
Iron levels in brain of rats	2 months	Iron levels in brain homogenate of rats in the three rat groups
Levels of Alpha-synuclein expression in brain of rats	2 months	Alpha-synuclein expression in brain of rats in different groups
Iron levels	6 months	Serum iron levels in ischemic patients and control
Levels of Lymphocyte activation gene-3 expression in brain of rats	2 months	lymphocyte activation gene-3 expression in brain of rats in different groups

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt