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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06211725
Other study ID # VANGAS
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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