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Brain IschemiaNCT05748587

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

An observational study of Brain Ischemia, run by Aswan University Hospital at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 70 years
Conditions the study is for
Brain Ischemia
What is being tested?
Serum Iron, RBCs Alpha-synuclein and Serum Soluble lymphocyte activation gene
How many people
48 participants
Where
1 siteEgypt
Study dates
1 Apr 2023to 1 Apr 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with neurological symptoms of acute ischemic stroke

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Aswan University Hospital

    Aswān, 81528

Other trials in Egypt

About this study

Official title: 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?
Conditions
Brain Ischemia
Being tested
Serum Iron, RBCs Alpha-synuclein, Serum Soluble lymphocyte activation gene, Brain computed tomography, Brain Iron
Medical subject headings
Brain Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Serum IronDiagnostic test

    Serum iron levels in study groups

  • RBCs Alpha-synucleinDiagnostic test

    Also called α-syn

    α-syn levels in RBCs

  • Serum Soluble lymphocyte activation geneDiagnostic test

    Also called sLAG-3

    sLAG-3 in the serum of study groups

  • Brain computed tomographyRadiation

    Also called CT

    Brain CT of patients after admission

  • Brain IronDiagnostic test

    Iron in brain homogenate of rats

  • Brain Alpha-synucleinDiagnostic test

    Also called α-syn

    α-syn expression in rat's brain

  • Brain lymphocyte activation geneDiagnostic test

    Also called LAG-3

    LAG-3 expression in rat's brain

  • DeferoxamineDrug

    intramuscular deferoxamine (200 mg/kg) injection to rats

Study groups in NCT05748587
Study groupRoleWhat they receive
Control24 healthy age and sex-matched controls
Receives: Diagnostic Test: Serum Iron; Diagnostic Test: RBCs Alpha-synuclein; Diagnostic Test: Serum Soluble lymphocyte activation gene; Radiation: Brain computed tomography
Patients with acute Ischemic stroke24 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.
Receives: Diagnostic Test: Serum Iron; Diagnostic Test: RBCs Alpha-synuclein; Diagnostic Test: Serum Soluble lymphocyte activation gene; Radiation: Brain computed tomography
Control rats8 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.
Receives: Diagnostic Test: Brain Iron; Diagnostic Test: Brain Alpha-synuclein; Diagnostic Test: Brain lymphocyte activation gene
Rats with ischemic stroke8 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.
Receives: Diagnostic Test: Brain Iron; Diagnostic Test: Brain Alpha-synuclein; Diagnostic Test: Brain lymphocyte activation gene
Rats with ischemic stroke + deferoxamine8 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.
Receives: Diagnostic Test: Brain Iron; Diagnostic Test: Brain Alpha-synuclein; Diagnostic Test: Brain lymphocyte activation gene; Drug: Deferoxamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Iron levels

    Serum iron levels in ischemic patients and control

    Measured: 6 months

  2. Alpha-synuclein levels

    Alpha-synuclein levels in RBCs in ischemic patients and control

    Measured: 6 months

  3. Levels of Soluble lymphocyte activation gene-3

    Serum soluble lymphocyte activation gene-3 in ischemic patients and control

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. Iron levels in brain of rats

    Iron levels in brain homogenate of rats in the three rat groups

    Measured: 2 months

  6. Levels of Alpha-synuclein expression in brain of rats

    Alpha-synuclein expression in brain of rats in different groups

    Measured: 2 months

  7. Levels of Lymphocyte activation gene-3 expression in brain of rats

    lymphocyte activation gene-3 expression in brain of rats in different groups

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2023
  2. Study start1 Apr 2023
  3. Primary completion1 Mar 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05748587
Sponsor's protocol ID
sLAG-3 in brain ischemia
Status last verified
Jun 2024
First submitted
20 Feb 2023
Last updated
25 Jun 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34675870

  • 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.

    PubMed 35847179

  • 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.

    PubMed 31767524

  • 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.

    PubMed 35170503

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Ischemia, run by Aswan University Hospital at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Iron levels (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05748587, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.

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