NF-L Chain Measurement in Acute Ischemic Stroke

November 4, 2023 updated by: Kerolous Hana Henein, Assiut University

Role of Neurofilament Light Chain as a Diagnostic Tool and Predictor of Outcome of Acute Ischemic Stroke.

  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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

population will include 3 groups, group A : will include patients of acute ischemic stroke - developing focal neurological symptoms in first 24 hour - of age between 18 - 70 year old.

group B : will include patients of chronic ischemic stroke - developing focal neurological symptoms for 6-12 month - of age between 18 - 70 year old. group C : will be healthy controls of age above 18 y.o

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Diagnostic test: 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.
B
Patients with chronic ischemic stroke , having these symptoms for 6-12 month
Diagnostic test: 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.
C
Healthy controls
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring neurofilament light chain in stroke patients
Time Frame: baseline
correlation between levels of neurofilament light chain with severity and functional outcome of stroke patients
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

October 13, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 4, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NF-L chain in acute stroke

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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