Clinical trial NCT05748587: Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in Ischemic Stroke
Official title: Role of Iron, Alpha-Synuclein, and Lymphocyte-activation Gene-3 in the Pathophysiology of Ischemic Stroke in Human and Albino Rats
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Ischemia
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with neurological symptoms of acute ischemic stroke

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?


Eligibility criteria: 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.

Primary outcomes:
measure: Iron levels
timeFrame: 6 months
measure: Alpha-synuclein levels
timeFrame: 6 months
measure: Levels of Soluble lymphocyte activation gene-3
timeFrame: 6 months
measure: levels of iron, alpha-synuclein, and soluble lymphocyte activation in relation to stroke severity and infarction size
timeFrame: 6 months
measure: Iron levels in brain of rats
timeFrame: 2 months
measure: Levels of Alpha-synuclein expression in brain of rats
timeFrame: 2 months
measure: Levels of Lymphocyte activation gene-3 expression in brain of rats
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University Hospital
Study officials:
affiliation: Aswan University Hospital
name: Asmaa Abdelmageed Muhammed
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.