NF-L Chain Measurement in Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2025-08-01

Brief Summary

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1. Using neurofilament light chain as a diagnostic tool and predictor of outcome of acute ischemic stroke
2. Using neurofilament light chain in detecting severity in old ischemic stroke

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Detailed Description

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Ischemic stroke is the second leading cause of death and disability with symptoms ranging from complete remission within 24 h (transient ischemic attack, TIA) to lasting disability in the form of cognitive dysfunction, physical disability, and complete dependency on others. The currently available acute treatments of intravenous administration of tissue plasminogen activator (2) and mechanical thrombectomy are associated with rare but severe side effects such as hemorrhage of the brain and body. Because these treatments require rapid initiation to be effective, some patients may be exposed to side effects without benefiting from the treatment. We need, therefore, to identify biomarkers that can predict functional outcome, especially in the early phases, and improve our understanding of the pathophysiological mechanisms underlying tissue damage following a stroke to develop new advanced therapeutic strategies.

When brain damage occurs, neuronal injury and disruption of axonal membranes lead to the release of cytoskeleton proteins, such as neurofilaments (NFs), into the interstitial fluid and eventually into the cerebrospinal fluid (CSF) and blood. NFs are highly specific structural, neuronal cytoskeletal proteins that consist of four NF subunits: NF light (NF-L), NF medium (NFM), and NF heavy (NF-H) chains, and alpha-internexin.

NF-L has been studied as a potential CSF and circulation biomarker for a wide range of neurological disorders (3), including cerebral small vessel disease (4) and subacute ischemic stroke.

The inflammatory process that ensues after a stroke destabilizes the blood-brain barrier (BBB) and contributes to neuro-axonal damage, thereby increasing the release of NFs and glial and inflammatory markers into the CSF and blood.

Ischemic stroke has recently been shown to cause persistent elevations in serum NF-L that correlated with infarct volumes and recurrent ischemic lesions.

So, Measuring serum level of NF-L will be promising as a biomarker for predicting severity of stroke symptoms and its functional outcome. So, we can predict prognosis of these cases.

NF-L levels obtained within 24 h of symptom onset in the blood of ischemic stroke and TIA patients will be associated with diagnosis of these patients and as a predictor for functional outcome of these patients.

These patients after 1 and 3 months will be assessed again clinically by NIHSS and mRS to assess their outcome and detecting possibility of recurrence.

the investigators will also measure serum NF-L levels in old ischemic stroke patients having stroke of 6 to 12 month duration, as NF-L will be used as a predictor of severity of ischemic stroke in these patients.

the investigators will also measure NF-L in healthy controls to compare its level between the healthy and diseased cases.

the investigators will also measure infarct size in MR imaging, measure media-intima thickness of carotid artery, and correlate their findings with NF-L serum level to predict stroke severity and functional outcome.

Conditions

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Acute Stroke

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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A

Patients with acute ischemic stroke having focal neurological deficits lasting for more than 24 hour with relevant lesion in brain computerized tomography (CT) or magnetic resonance (MR) image

Measurement of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

Serum samples will be collected into a serum gel with clotting activator tube (Sarstedt). After delivery to the laboratory, the serum samples were centrifuged at 2500 × g for 6 min at 4 Celsius degree, then aliquoted into at least three vials (0.3 mL per vial) and stored at -70 Celsius degree until the analysis.

B

Patients with chronic ischemic stroke , having these symptoms for 6-12 month

Measurement of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

Serum samples will be collected into a serum gel with clotting activator tube (Sarstedt). After delivery to the laboratory, the serum samples were centrifuged at 2500 × g for 6 min at 4 Celsius degree, then aliquoted into at least three vials (0.3 mL per vial) and stored at -70 Celsius degree until the analysis.

C

Healthy controls

Measurement of neurofilament light chain

Intervention Type DIAGNOSTIC_TEST

Serum samples will be collected into a serum gel with clotting activator tube (Sarstedt). After delivery to the laboratory, the serum samples were centrifuged at 2500 × g for 6 min at 4 Celsius degree, then aliquoted into at least three vials (0.3 mL per vial) and stored at -70 Celsius degree until the analysis.

Interventions

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Measurement of neurofilament light chain

Serum samples will be collected into a serum gel with clotting activator tube (Sarstedt). After delivery to the laboratory, the serum samples were centrifuged at 2500 × g for 6 min at 4 Celsius degree, then aliquoted into at least three vials (0.3 mL per vial) and stored at -70 Celsius degree until the analysis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* both sex
* Age between 18 to 70 years old.
* symptoms suggestive of acute ischemic stroke: presenting within 24 hours of onset of these symptoms
* for chronic ischemic patients : Duration of 6 to 12 month of development of ischemic symptoms
* for control cases : Healthy people

Exclusion Criteria

* presence of space occupying lesion
* presence of sinus thrombosis
* presence of hemorrhagic stroke
* presence of sub-arachnoid hemorrhage
* presence of Alzheimer disease, Parkinson disease, multiple sclerosis, amyotrophic lateral sclerosis, or traumatic brain injury

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No