NF-L Chain Measurement in Acute Ischemic Stroke
Role of Neurofilament Light Chain as a Diagnostic Tool and Predictor of Outcome of Acute Ischemic Stroke.
1 other identifier
observational
150
0 countries
N/A
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2023
CompletedFirst Posted
Study publicly available on registry
October 19, 2023
CompletedStudy Start
First participant enrolled
November 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedNovember 7, 2023
November 1, 2023
1.3 years
October 13, 2023
November 4, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
measuring neurofilament light chain in stroke patients
correlation between levels of neurofilament light chain with severity and functional outcome of stroke patients
baseline
Study Arms (3)
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
B
Patients with chronic ischemic stroke , having these symptoms for 6-12 month
C
Healthy controls
Interventions
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.
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (5)
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.
PMID: 36181119BACKGROUNDBanks 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.
PMID: 17272767BACKGROUNDRevendova 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.
PMID: 36130459BACKGROUNDGaiottino 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.
PMID: 24073237BACKGROUNDNielsen 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.
PMID: 32595585BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident
Study Record Dates
First Submitted
October 13, 2023
First Posted
October 19, 2023
Study Start
November 1, 2023
Primary Completion
March 1, 2025
Study Completion
August 1, 2025
Last Updated
November 7, 2023
Record last verified: 2023-11