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Extracranial Carotid Artery AneurysmNCT05828576

ECAA Brain MRI: Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease

An observational study of Extracranial Carotid Artery Aneurysm, run by UMC Utrecht at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In order to understand which ECAA patients benefit from medical therapy, more should be known about the possible outcomes of this rare disease. Small vessel disease seen on brain MRI's could be a good marker to assess possible silent cerebrovascular disease caused by ECAA's, suggesting underlying generalized vascular… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Extracranial Carotid Artery Aneurysm
What is being tested?
MRI
How many people
50 participants
Where
1 siteNetherlands
Study dates
30 Mar 2023to 1 Apr 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population comprises patients with extracranial carotid artery aneurysm (ECAA) from the Netherlands, aged 18 years or older, of any gender, race, and medical history except for those with neurovascular diseases such as Parkinson's disease and multiple sclerosis.

Who may be able to join

  • Patient older than 18 years registered in the CAR treated with conservative therapy
  • Willingness and ability to participate in all scheduled procedures outlined in the protocol
  • Understanding of the Dutch language
  • Patient is able and willing to give informed consent.
  • Subjects registered in the CAR that have undergone surgical or endovascular treatment of the ECAA
  • Contradictions for MRI, such as 1) metallic objects in or around the body (e.g. cardiac implantable electronic device such as pacemakers and implantable cardioverter defibrillators (ICD); 2) claustrophobia, 3) pregnancy.
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  • Other major neurological or psychiatric conditions affecting the brain and interfering with the study design (e.g. multiple sclerosis, epilepsy, Parkinson's disease, vascular dementia)
  • Unable to read or write the patient information letter and broad consent file
  • Patients who have a life expectancy of less than two years due to a pre-existing condition e.g. cancer

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting

  • UMCU

    Utrecht, South Holland

    Gert Jan de Borst, +31-88-7556965, g.j.deBorst-2@umcutrecht.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease

In order to understand which ECAA patients benefit from medical therapy, more should be known about the possible outcomes of this rare disease. Small vessel disease seen on brain MRI's could be a good marker to assess possible silent cerebrovascular disease caused by ECAA's, suggesting underlying generalized vascular disease. With this knowledge, medical therapy for ECAA patients can be optimized and individualized to treat possible generalized vascular disease, aiding physicians in choosing a treatment strategy.

Read the detailed description

The ECAA brain MRI study is a monocenter longitudinal observational cohort study, initiated by the Department of Vascular Surgery at the University Medical Center Utrecht (UMCU), The Nederlands. The study aims to recruit 50 participants with an extracranial carotid artery aneurysm (ECAA) who are currently receiving conservative treatment. Patients will undergo MRI at baseline and after 2 years of follow-up. The expected duration of the study is approximately 3 years. The study will be conducted according to the principles of the Declaration of Helsinki (64th WMA General Assembly, Fortaleza, Brazil, October 2013). The medical ethics committee of the UMCU has approved the study. To be eligible to be included in the ECAA brain MRI, patients must be enrolled in the Carotid Aneurysm Registry (CAR, NCT02229370)

Being tested
MRI

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRIDiagnostic test

    Patients will be asked for two additional control visits in the hospital. Overview of measurements: Included subject will visit the UMCU at two occasions. The first MRI scan will be the baseline MRI, and the second MRI will take place after 2 years of follow-up. Additional follow-up data will be collected through medical records reporting on regular follow-up.

Study groups in NCT05828576
Study groupRoleWhat they receive
ECAA patientECAA patient recieving conservative treatment
Receives: Diagnostic Test: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Small vessel disease in ECAA patients

    To assess the presence of ipsilateral small vessel disease (i.e. WMHs, lacunes, microbleeds, perivascular spaces, and recent small subcortical infarcts) based on 3 tesla (3T) brain MRI in patients with ECAA

    Measured: 2023-2025

Secondary outcomes (6)

  1. Small vessel disease in ECAA patients in time

    To investigate the progression of small vessel disease over time. Title: Progression of small vessel disease in ECAA patients over time

    Description: This study aims to investigate the progression of small vessel disease in ECAA patients over a two-year period, as measured by white matter hyperintensity (WMH) volume in ml on MRI scans at baseline and two-year follow-up, as well as the presence of lacunar infarcts on MRI scans.

    Unit of measure: WMH volume in ml Measurement tool: MRI scans Other small vessel disease: Presence of lacunar infarcts, perisvascular spacesm, lacunes, microbleeds on MRI scans, counted manually

    Measured: 24months

  2. Small vessel disease uni/bilateral

    Outcome Measure Title: Unilateral vs. Bilateral Small Vessel Disease in ECAA Patients Description: This outcome measure will assess whether small vessel disease in ECAA patients occurs unilaterally or bilaterally. White matter hyperintensities will be measured by calculating the volume of white matter hyperintensities (WMH) in milliliters (ml) on MRI scans. Unilateral small vessel disease will be defined as WMH volume greater on the same side as the ECAA, while bilateral small vessel disease will be defined as WMH volume roughly equal on both sides. Other small vessel disease will be scored as a number (as a number of lacunair infarcts) and comapered uni- an bilaterally to the affected carotid side.

    Measured: 24months

  3. Silent brain lesions

    To investigate the presence and localisation of silent brain lesions in ECAA patients

    Measured: 24months

  4. Aneurysm morphology.

    To assess the association between aneurysm characteristics and small vessel disease burden.Outcome Measure Title: Correlation Between Aneurysm Characteristics and Small Vessel Disease Burden Unit of Measure: Correlation Coefficient (r) Measurement Tool: Statistical Analysis Description: The correlation between aneurysm characteristics (such as size, location, and shape) and small vessel disease burden (such as white matter hyperintensities and lacunar infarcts) will be assessed using a correlation analysis. The correlation coefficient (r) will be calculated to determine the strength and direction of the relationship between the two variables.

    Measured: 24months

  5. Flow in ECAA

    To investigate the pulsatility in the in the carotid artery based on 3T MRI imaging.

    Outcome Measure Title: Pulsatility Index (PI) in the Carotid Artery Measured by 3T MRI Imaging Unit of Measure: Pulsatility Index (%) Measurement Tool: 3T MRI Imaging Description: The pulsatility index (PI) will be calculated by measuring the peak systolic velocity and end-diastolic velocity of blood flow in the carotid artery using 3T MRI imaging. The PI will be calculated using the following formula: PI = (peak systolic velocity - end-diastolic velocity) / mean velocity.

    Measured: 24months

  6. Flow in ECAA

    To investigate the distensibility in the in the carotid artery based on 3T MRI. Outcome Measure Title: Carotid Artery Distensibility Measured by 3T MRI Imaging Unit of Measure: Distensibility (mmHg^-1 x 10^-3) Measurement Tool: 3T MRI Imaging Description: The distensibility of the carotid artery will be measured using 3T MRI imaging by acquiring cine images of the carotid artery during the cardiac cycle. The distensibility will be calculated using the following formula: distensibility = [(A_max - A_min) / A_min] / [Pulse pressure], where A_max and A_min are the maximum and minimum areas of the carotid artery lumen during the cardiac cycle, respectively, and Pulse pressure is the difference between systolic and diastolic blood pressures.

    Measured: 24months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2023
  2. Study start30 Mar 2023
  3. Primary completion1 Apr 2025 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05828576
Sponsor's protocol ID
22-781
Status last verified
Apr 2023
First submitted
30 Mar 2023
Last updated
25 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Welleweerd JC, den Ruijter HM, Nelissen BG, Bots ML, Kappelle LJ, Rinkel GJ, Moll FL, de Borst GJ. Management of extracranial carotid artery aneurysm. Eur J Vasc Endovasc Surg. 2015 Aug;50(2):141-7. doi: 10.1016/j.ejvs.2015.05.002. Epub 2015 Jun 24.

    PubMed 26116488

  • van Laarhoven CJHCM, Rots ML, Pourier VEC, Jorritsma NKN, Leiner T, Hendrikse J, Vergouwen MDI, de Borst GJ. Gadolinium Enhancement of the Aneurysm Wall in Extracranial Carotid Artery Aneurysms. AJNR Am J Neuroradiol. 2020 Mar;41(3):501-507. doi: 10.3174/ajnr.A6442. Epub 2020 Feb 27.

    PubMed 32115417

  • Ghaznawi R, Geerlings MI, Jaarsma-Coes M, Hendrikse J, de Bresser J; UCC-Smart Study Group. Association of White Matter Hyperintensity Markers on MRI and Long-term Risk of Mortality and Ischemic Stroke: The SMART-MR Study. Neurology. 2021 Apr 27;96(17):e2172-e2183. doi: 10.1212/WNL.0000000000011827. Epub 2021 Mar 16.

    PubMed 33727406

  • Wardlaw JM, Smith EE, Biessels GJ, Cordonnier C, Fazekas F, Frayne R, Lindley RI, O'Brien JT, Barkhof F, Benavente OR, Black SE, Brayne C, Breteler M, Chabriat H, Decarli C, de Leeuw FE, Doubal F, Duering M, Fox NC, Greenberg S, Hachinski V, Kilimann I, Mok V, Oostenbrugge Rv, Pantoni L, Speck O, Stephan BC, Teipel S, Viswanathan A, Werring D, Chen C, Smith C, van Buchem M, Norrving B, Gorelick PB, Dichgans M; STandards for ReportIng Vascular changes on nEuroimaging (STRIVE v1). Neuroimaging standards for research into small vessel disease and its contribution to ageing and neurodegeneration. Lancet Neurol. 2013 Aug;12(8):822-38. doi: 10.1016/S1474-4422(13)70124-8.

    PubMed 23867200

Questions about this trial

What is this clinical trial studying?

An observational study of Extracranial Carotid Artery Aneurysm, run by UMC Utrecht at 1 site in Netherlands.

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 9 inclusion and 0 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 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Small vessel disease in ECAA patients (time frame: 2023-2025). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05828576, which also lists 4 linked publications.

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 25 Apr 2023.

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