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

Carotid Artery Diseases Clinical Trial

— VANGAS  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211725
• Other study ID #: VANGAS
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Michael / John-Ih / MG Gliem / Lee, MD
• Phone: +49174 - 271 57 39
• Email: michael.gliem[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carotid Artery Diseases
• Carotid Artery Plaque
• Carotid Artery Stenosis
• Carotid Stenosis
• Constriction, Pathologic

Locations

Country	Name	City	State
Germany	University hospital Düsseldorf	Düsseldorf	NRW
Germany	Kliniken Maria Hilf GmbH	Mönchengladbach	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria)	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.	24 months
Secondary	Correlation of NF-L/GFAP with functional outcome (modified rankin scale)	The amount of NF-L and GFAP in the blood of patients with stenosis of a brain-supplying artery correlates with functional outcome after symptomatic stenosis	24 months
Secondary	Correlation of NF-L/GFAP with progression of stenosis (NASCET-Criteria)	The amount of NF-L and GFAP in the blood of patients with stenosis of a brain-supplying artery correlates with the progression of the stenosis (increase or decrease).	24 months
Secondary	Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)	The amount of NF-L and GFAP in the blood of patients with stenosis of a brain-supplying artery allows differentiation between future symptomatic and asymptomatic stenosis	24 months