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

NCT05828576 | Unknown DMC

• 1 other identifier: 22-781
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Extracranial Carotid Artery Aneurysm

Outcome Measures

Primary Outcomes (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

  2023-2025

Secondary Outcomes (6)

• Small vessel disease in ECAA patients in time

  24months

• Small vessel disease uni/bilateral

  24months

• Silent brain lesions

  24months

• Aneurysm morphology.

  24months

• Flow in ECAA

  24months

Study Arms (1)

ECAA patient

ECAA patient recieving conservative treatment

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_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.

ECAA patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMCU

Utrecht, South Holland, Netherlands

RECRUITING

Related Publications (4)

• 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.

  PMID: 26116488 RESULT

• 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.

  PMID: 32115417 RESULT

• 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.

  PMID: 33727406 RESULT

• 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.

  PMID: 23867200 RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 25, 2023
• Study Start: March 30, 2023
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)