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

Brain Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748587
• Other study ID #: sLAG-3 in brain ischemia
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Aswan University Hospital
• Contact: Asmaa Abdelmageed Muhammed, Lecturer
• Phone: 01098548122
• Email: asmaa.ali[@]med.aswu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Ischemia
• Ischemic Stroke

Intervention

Diagnostic Test:
• Serum Iron
Serum iron levels in study groups
• RBCs Alpha-synuclein
a-syn levels in RBCs
• Serum Soluble lymphocyte activation gene
sLAG-3 in the serum of study groups

Radiation:
• Brain computed tomography
Brain CT of patients after admission

Diagnostic Test:
• Brain Iron
Iron in brain homogenate of rats
• Brain Alpha-synuclein
a-syn expression in rat's brain
• Brain lymphocyte activation gene
LAG-3 expression in rat's brain

Drug:
• Deferoxamine
intramuscular deferoxamine (200 mg/kg) injection to rats

Locations

Country	Name	City	State
Egypt	Aswan University Hospital	Aswan

Sponsors (1)

Lead Sponsor	Collaborator
Aswan University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

Malfertheiner K, Stefanova N, Heras-Garvin A. The Concept of alpha-Synuclein Strains and How Different Conformations May Explain Distinct Neurodegenerative Disorders. Front Neurol. 2021 Oct 5;12:737195. doi: 10.3389/fneur.2021.737195. eCollection 2021. — View Citation

Wu Q, Wei C, Guo S, Liu J, Xiao H, Wu S, Wu B, Liu M. Acute iron overload aggravates blood-brain barrier disruption and hemorrhagic transformation after transient focal ischemia in rats with hyperglycemia. IBRO Neurosci Rep. 2022 Jul 3;13:87-95. doi: 10.1016/j.ibneur.2022.06.006. eCollection 2022 Dec. — View Citation

Yoon CW, Park HK, Bae EK, Rha JH. Sleep Apnea and Early Neurological Deterioration in Acute Ischemic Stroke. J Stroke Cerebrovasc Dis. 2020 Feb;29(2):104510. doi: 10.1016/j.jstrokecerebrovasdis.2019.104510. Epub 2019 Nov 22. — View Citation

Zhao L, Wang H, Xu K, Liu X, He Y. Update on lymphocyte-activation gene 3 (LAG-3) in cancers: from biological properties to clinical applications. Chin Med J (Engl). 2022 May 20;135(10):1203-1212. doi: 10.1097/CM9.0000000000001981. — View Citation

Outcome

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