Clinical trial NCT06211725: The VANGAS-Trial. The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Stenosis
Carotid Artery Stenosis Asymptomatic
Carotid Artery Diseases
Carotid Artery Plaque
Keywords: Carotid Artery Stenosis
Carotid Artery Plaque
Carotid Artery Disease
Carotid Artery Stenosis asymptomatic
Carotid artery stenosis biomarker
carotid artery nfl
carotid artery gfap
Carotid Artery Plaque Biomarker
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients are included from our and the cooperating neurological clinics and practices

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 \&#34;neurofilament light chain\&#34; (NFL), which is already established in the diagnosis of dementia. As a component of the cytoskeleton of neurons, it is released into the patient\&#39;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.


Eligibility criteria: 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\&amp;#39;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

Primary outcomes:
measure: Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)
timeFrame: 24 months
Secondary outcomes:
measure: Correlation of NF-L/GFAP with functional outcome (modified rankin scale)
timeFrame: 24 months
measure: Correlation of NF-L/GFAP with progression of stenosis (NASCET-Criteria)
timeFrame: 24 months
measure: Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)
timeFrame: 24 months
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: University hospital Düsseldorf
state: NRW
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH
state: NRW
Study officials:
References: