NCT05748587

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

11 months

First QC Date

February 20, 2023

Last Update Submit

June 24, 2024

Conditions

Brain Ischemia

Outcome Measures

Primary Outcomes (7)

  • Iron levels

    Serum iron levels in ischemic patients and control

    6 months

  • Alpha-synuclein levels

    Alpha-synuclein levels in RBCs in ischemic patients and control

    6 months

  • Levels of Soluble lymphocyte activation gene-3

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

    6 months

  • 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

  • Iron levels in brain of rats

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

    2 months

  • Levels of Alpha-synuclein expression in brain of rats

    Alpha-synuclein expression in brain of rats in different groups

    2 months

  • 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

Study Arms (5)

Control

24 healthy age and sex-matched controls

Diagnostic Test: Serum IronDiagnostic Test: RBCs Alpha-synucleinDiagnostic Test: Serum Soluble lymphocyte activation geneRadiation: Brain computed tomography

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 IronDiagnostic Test: RBCs Alpha-synucleinDiagnostic Test: Serum Soluble lymphocyte activation geneRadiation: Brain computed tomography

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 IronDiagnostic Test: Brain Alpha-synucleinDiagnostic Test: Brain lymphocyte activation gene

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 IronDiagnostic Test: Brain Alpha-synucleinDiagnostic Test: Brain lymphocyte activation gene

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 IronDiagnostic Test: Brain Alpha-synucleinDiagnostic Test: Brain lymphocyte activation geneDrug: Deferoxamine

Interventions

Serum IronDIAGNOSTIC_TEST

Serum iron levels in study groups

ControlPatients with acute Ischemic stroke
RBCs Alpha-synucleinDIAGNOSTIC_TEST

α-syn levels in RBCs

Also known as: α-syn
ControlPatients with acute Ischemic stroke
Serum Soluble lymphocyte activation geneDIAGNOSTIC_TEST

sLAG-3 in the serum of study groups

Also known as: sLAG-3
ControlPatients with acute Ischemic stroke
Brain computed tomographyRADIATION

Brain CT of patients after admission

Also known as: CT
ControlPatients with acute Ischemic stroke
Brain IronDIAGNOSTIC_TEST

Iron in brain homogenate of rats

Control ratsRats with ischemic strokeRats with ischemic stroke + deferoxamine
Brain Alpha-synucleinDIAGNOSTIC_TEST

α-syn expression in rat's brain

Also known as: α-syn
Control ratsRats with ischemic strokeRats with ischemic stroke + deferoxamine
Brain lymphocyte activation geneDIAGNOSTIC_TEST

LAG-3 expression in rat's brain

Also known as: LAG-3
Control ratsRats with ischemic strokeRats with ischemic stroke + deferoxamine
DeferoxamineDRUG

intramuscular deferoxamine (200 mg/kg) injection to rats

Rats with ischemic stroke + deferoxamine

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with neurological symptoms of acute ischemic stroke

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University Hospital

Aswān, 81528, Egypt

Location

Related 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.

    PMID: 34675870BACKGROUND

  • 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.

    PMID: 35847179BACKGROUND

  • 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.

    PMID: 31767524BACKGROUND

  • 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.

    PMID: 35170503BACKGROUND

MeSH Terms

Conditions

Brain Ischemia

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic Acids

Study Officials

  • Asmaa Abdelmageed Muhammed

    Aswan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

February 20, 2023

First Posted

February 28, 2023

Study Start

April 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 1, 2024

Last Updated

June 25, 2024

Record last verified: 2024-06

Locations

EG(1)