Acute StrokeNCT06090058
NF-L Chain Measurement in Acute Ischemic Stroke
An observational study of Acute Stroke, run by Assiut University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Measurement of neurofilament light chain
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2023to 1 Aug 2025
- 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 18 to 70 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of Neurofilament Light Chain as a Diagnostic Tool and Predictor of Outcome of Acute Ischemic Stroke.
- Using neurofilament light chain as a diagnostic tool and predictor of outcome of acute ischemic stroke
- Using neurofilament light chain in detecting severity in old ischemic stroke
Read the 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.
- Conditions
- Acute Stroke
- Being tested
- Measurement of neurofilament light chain
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of neurofilament light chainDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Measurement of neurofilament light chain | |
| B | Patients with chronic ischemic stroke , having these symptoms for 6-12 month Receives: Diagnostic Test: Measurement of neurofilament light chain | |
| C | Healthy controls Receives: Diagnostic Test: Measurement of neurofilament light chain |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring neurofilament light chain in stroke patients
correlation between levels of neurofilament light chain with severity and functional outcome of stroke patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Nov 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerolous Hana Henein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090058
- Sponsor's protocol ID
- NF-L chain in acute stroke
- Status last verified
- Nov 2023
- First submitted
- 13 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ahn JW, Hwang J, Lee M, Kim JH, Cho HJ, Lee HW, Eun MY. Serum neurofilament light chain levels are correlated with the infarct volume in patients with acute ischemic stroke. Medicine (Baltimore). 2022 Sep 30;101(39):e30849. doi: 10.1097/MD.0000000000030849.
PubMed 36181119Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1.
PubMed 17272767Revendova KZ, Zeman D, Bunganic R, Karasova K, Volny O, Bar M, Kusnierova P. Serum neurofilament levels in patients with multiple sclerosis: A comparison of SIMOA and high sensitivity ELISA assays and contributing factors to ELISA levels. Mult Scler Relat Disord. 2022 Nov;67:104177. doi: 10.1016/j.msard.2022.104177. Epub 2022 Sep 11.
PubMed 36130459Gaiottino J, Norgren N, Dobson R, Topping J, Nissim A, Malaspina A, Bestwick JP, Monsch AU, Regeniter A, Lindberg RL, Kappos L, Leppert D, Petzold A, Giovannoni G, Kuhle J. Increased neurofilament light chain blood levels in neurodegenerative neurological diseases. PLoS One. 2013 Sep 20;8(9):e75091. doi: 10.1371/journal.pone.0075091. eCollection 2013.
PubMed 24073237Nielsen HH, Soares CB, Hogedal SS, Madsen JS, Hansen RB, Christensen AA, Madsen C, Clausen BH, Frich LH, Degn M, Sibbersen C, Lambertsen KL. Acute Neurofilament Light Chain Plasma Levels Correlate With Stroke Severity and Clinical Outcome in Ischemic Stroke Patients. Front Neurol. 2020 Jun 11;11:448. doi: 10.3389/fneur.2020.00448. eCollection 2020.
PubMed 32595585
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neurofilament Light Chain as a Diagnostic Tool and Predictor of Outcome of Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT06090058
- Acronym / sponsor ID
- NF-L chain in acute stroke
- Conditions
- Acute Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Using neurofilament light chain as a diagnostic tool and predictor of outcome of acute ischemic stroke
- Using neurofilament light chain in detecting severity in old ischemic stroke
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Diagnostic Test: Measurement of neurofilament light chainPatients 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 |
| B | – | Diagnostic Test: Measurement of neurofilament light chainPatients with chronic ischemic stroke , having these symptoms for 6-12 month |
| C | – | Diagnostic Test: Measurement of neurofilament light chainHealthy controls |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of neurofilament light chainSerum 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. | Diagnostic test | A, B, C |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 36181119Ahn JW, Hwang J, Lee M, Kim JH, Cho HJ, Lee HW, Eun MY. Serum neurofilament light chain levels are correlated with the infarct volume in patients with acute ischemic stroke. Medicine (Baltimore). 2022 Sep 30;101(39):e30849. doi: 10.1097/MD.0000000000030849.
- Background: PubMed 17272767Banks JL, Marotta CA. Outcomes validity and reliability of the modified Rankin scale: implications for stroke clinical trials: a literature review and synthesis. Stroke. 2007 Mar;38(3):1091-6. doi: 10.1161/01.STR.0000258355.23810.c6. Epub 2007 Feb 1.
- Background: PubMed 36130459Revendova KZ, Zeman D, Bunganic R, Karasova K, Volny O, Bar M, Kusnierova P. Serum neurofilament levels in patients with multiple sclerosis: A comparison of SIMOA and high sensitivity ELISA assays and contributing factors to ELISA levels. Mult Scler Relat Disord. 2022 Nov;67:104177. doi: 10.1016/j.msard.2022.104177. Epub 2022 Sep 11.
- Background: PubMed 24073237Gaiottino J, Norgren N, Dobson R, Topping J, Nissim A, Malaspina A, Bestwick JP, Monsch AU, Regeniter A, Lindberg RL, Kappos L, Leppert D, Petzold A, Giovannoni G, Kuhle J. Increased neurofilament light chain blood levels in neurodegenerative neurological diseases. PLoS One. 2013 Sep 20;8(9):e75091. doi: 10.1371/journal.pone.0075091. eCollection 2013.
- Background: PubMed 32595585Nielsen HH, Soares CB, Hogedal SS, Madsen JS, Hansen RB, Christensen AA, Madsen C, Clausen BH, Frich LH, Degn M, Sibbersen C, Lambertsen KL. Acute Neurofilament Light Chain Plasma Levels Correlate With Stroke Severity and Clinical Outcome in Ischemic Stroke Patients. Front Neurol. 2020 Jun 11;11:448. doi: 10.3389/fneur.2020.00448. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Assiut University.
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 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kerolous Hana Henein (01140623624, keroloushana@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring neurofilament light chain in stroke patients (time frame: baseline). 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 NCT06090058, which also lists 5 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 7 Nov 2023.