Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06211725
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2024-01-08
Brief Title:
The VANGAS-Trial The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis
Sponsor:
Heinrich-Heine University Duesseldorf
Organization:
Heinrich-Heine University Duesseldorf
Study Overview
Official Title:
The VANGAS-Trial The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VANGAS
Brief Summary:
Stroke is the second leading cause of death and the third leading cause of disability worldwide The cause is usually either a blockage or a severe narrowing of a cerebral artery An important part of stroke prevention is the diagnosis and clarification of stenosis in the arteries supplying the brain both inside and outside the skull in order to diagnose a high-grade stenosis at an early stage and offer the patient revascularization In particular asymptomatic carotid artery stenosis confronts the diagnosing physician with the question of whether revascularisation is necessary
Risk factors for stroke in asymptomatic carotid artery stenosis include contralateral TIA or cerebral infarction male gender rapid progression of the degree of stenosis plaque morphology clinically silent cerebral infarctions Doppler sonographic evidence of microemboli or reduced vasomotor reserve An established biomarker does not exist at this time A candidate for such a biomarker in the blood is the protein 34neurofilament light chain34 NFL which is already established in the diagnosis of dementia As a component of the cytoskeleton of neurons it is released into the patient39s blood when the cells are damaged and can be measured there Another candidate is glial fibrillary acid protein GFAP a part of the cytoskeleton of glial cells that is also released into the blood when glial cells are damaged A systematic investigation of the value of neurofilament light chain and the glial fibrillary acidic protein in the blood of patients with asymptomatic carotid stenosis is still lacking VANGAS determines the value of NFL and GFAP from the blood of patients with asymptomatic carotid stenosis to determine associations with the degree of stenosis the natural course of the stenosis increase or decrease and possible symptoms of the stenosis as well as the functional outcome after symptomatic stenosis
Risk factors for stroke in asymptomatic carotid artery stenosis include contralateral TIA or cerebral infarction male gender rapid progression of the degree of stenosis plaque morphology clinically silent cerebral infarctions Doppler sonographic evidence of microemboli or reduced vasomotor reserve An established biomarker does not exist at this time A candidate for such a biomarker in the blood is the protein 34neurofilament light chain34 NFL which is already established in the diagnosis of dementia As a component of the cytoskeleton of neurons it is released into the patient39s blood when the cells are damaged and can be measured there Another candidate is glial fibrillary acid protein GFAP a part of the cytoskeleton of glial cells that is also released into the blood when glial cells are damaged A systematic investigation of the value of neurofilament light chain and the glial fibrillary acidic protein in the blood of patients with asymptomatic carotid stenosis is still lacking VANGAS determines the value of NFL and GFAP from the blood of patients with asymptomatic carotid stenosis to determine associations with the degree of stenosis the natural course of the stenosis increase or decrease and possible symptoms of the stenosis as well as the functional outcome after symptomatic stenosis
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None