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Clinical Trials/NCT06211725
NCT06211725RecruitingNot Applicable

The VANGAS-Trial. The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis

Heinrich-Heine University, Duesseldorf2 sites in 1 country200 target enrollmentStarted: January 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
200
Locations
2
Primary Endpoint
Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)

Study Overview

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 "neurofilament light chain" (NFL), which is already established in the diagnosis of dementia. As a component of the cytoskeleton of neurons, it is released into the patient's 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
60 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 60- 80 years
  • 0-100 % stenosis of the internal carotid artery

Exclusion Criteria

  • Neurodegenerative diseases such as any form of dementia or Parkinson's disease
  • Polyneuropathy
  • Multiple sclerosis
  • Stroke (ischaemic or haemorrhagic) within the last 12 months
  • Transient ischaemic attack within the last 12 months
  • Neurotrauma within the last 12 months
  • Atrial fibrillation

Outcomes

Primary Outcomes

Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)

Time Frame: 24 months

The amount of NF-L and GFAP in the blood of patients with stenosis of a brain-supplying artery correlates with the degree of the stenosis.

Secondary Outcomes

  • Correlation of NF-L/GFAP with functional outcome (modified rankin scale)(24 months)
  • Correlation of NF-L/GFAP with progression of stenosis (NASCET-Criteria)(24 months)
  • Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)(24 months)

Investigators

Sponsor
Heinrich-Heine University, Duesseldorf
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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