Carotid Artery StenosisVANGASNCT06211725
The VANGAS-Trial. The Value of Neurofilament Light Chain and Glial Fibrillary Acid Protein in the Blood of Patients With Asymptomatic Carotid Artery Stenosis
An observational study of Carotid Artery Stenosis and Carotid Artery Stenosis Asymptomatic, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Carotid Artery Stenosis, Carotid Artery Stenosis Asymptomatic, Carotid Artery Diseases
- How many people
- 200 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients are included from our and the cooperating neurological clinics and practices
Who may be able to join
- Age 60- 80 years
- 0-100 % stenosis of the internal carotid artery
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Michael / John-Ih / MG Gliem / Lee, MD contact
Germany2 sites, 2 recruiting
- Recruiting
University hospital Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Michael / John-Ih / MG Gliem / Lee, MD, +49174 - 271 57 39, michael.gliem@med.uni-duesseldorf.de
Robin RJ Jansen, MD, 0174 - 271 57 39, robin.jansen@med.uni-duesseldorf.de
- Recruiting
Kliniken Maria Hilf GmbH
Mönchengladbach, North Rhine-Westphalia, 41063
Michael / John-Ih / MG Gliem / Lee, MD, 0174 - 271 57 39, michael.gliem@med.uni-duesseldorf.de
Robin RJ Jansen, MD, 0174 - 271 57 39, robin.jansen@med.uni-duesseldorf.de
About this study
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.
- 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
- Medical subject headings
- Carotid Stenosis, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| neurovascular patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Secondary outcomes (3)
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
Measured: 24 months
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).
Measured: 24 months
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start1 Jan 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06211725
- Sponsor's protocol ID
- VANGAS
- Acronym
- VANGAS
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06211725
- Acronym / sponsor ID
- VANGAS / VANGAS
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| neurovascular patients | – | – |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients are included from our and the cooperating neurological clinics and practices
Key inclusion criteria (2 listed)
- Age 60- 80 years
- 0-100 % stenosis of the internal carotid artery
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Correlation of NF-L/GFAP with functional outcome (modified rankin scale)
Time frame: 24 months
Correlation of NF-L/GFAP with progression of stenosis (NASCET-Criteria)
Time frame: 24 months
Correlation of NF-L/GFAP with future cerebral ischemia (Stroke / TIA)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Carotid Artery Stenosis
Active, not recruitingObservational study
Symptomatic Carotid Outcomes Registry
Carotid Stenosis, Ischemic Stroke
Not yet recruitingObservational study
PET-MR Imaging of Natriuretic Peptide Receptor C (NPR-C) in Carotid Atherosclerosis With 64Cu-NODAGA-CANF (Multisite)
Carotid Atherosclerosis, Carotid Artery Stenosis Asymptomatic
Not yet recruitingObservational study
A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population
Carotid Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael / John-Ih / MG Gliem / Lee, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis and Carotid Artery Stenosis Asymptomatic, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael / John-Ih / MG Gliem / Lee, MD (+49174 - 271 57 39, michael.gliem@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of NF-L/GFAP with degree of stenosis (NASCET-Criteria) (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.