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

January 8, 2024 updated by: Heinrich-Heine University, Duesseldorf

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients are included from our and the cooperating neurological clinics and practices

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
neurovascular patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of NF-L/GFAP with functional outcome (modified rankin scale)
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 functional outcome after symptomatic stenosis
24 months
Correlation of NF-L/GFAP with progression 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 progression of the stenosis (increase or decrease).
24 months
Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heinrich-Heine University, Duesseldorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 8, 2024

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Estimated)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 8, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VANGAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Carotid Artery Plaque

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe