NCT06211725

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 18, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 8, 2024

Last Update Submit

January 8, 2024

Conditions

Carotid Artery StenosisCarotid Artery Stenosis AsymptomaticCarotid Artery DiseasesCarotid Artery Plaque

Keywords

Carotid Artery StenosisCarotid Artery PlaqueCarotid Artery DiseaseCarotid Artery Stenosis asymptomaticCarotid artery stenosis biomarkercarotid artery nflcarotid artery gfapCarotid Artery Plaque Biomarker

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

neurovascular patients

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University hospital Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Kliniken Maria Hilf GmbH

Mönchengladbach, North Rhine-Westphalia, 41063, Germany

RECRUITING

MeSH Terms

Conditions

Carotid StenosisCarotid Artery Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Michael / John-Ih / MG Gliem / Lee, MD

CONTACT

+49174 - 271 57 39michael.gliem@med.uni-duesseldorf.de

Robin MD Jansen, MD

CONTACT

0174 - 271 57 39robin.jansen@med.uni-duesseldorf.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

January 1, 2023

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 18, 2024

Record last verified: 2024-01

Locations

DE(2)