Clinical trial NCT05828576: ECAA Brain MRI: Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease
Official title: Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Extracranial Carotid Artery Aneurysm
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Inclusion criteria are not met
* 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

Primary outcomes:
measure: Small vessel disease in ECAA patients
timeFrame: 2023-2025
Secondary outcomes:
measure: Small vessel disease in ECAA patients in time
timeFrame: 24months
measure: Small vessel disease uni/bilateral
timeFrame: 24months
measure: Silent brain lesions
timeFrame: 24months
measure: Aneurysm morphology.
timeFrame: 24months
measure: Flow in ECAA
timeFrame: 24months
measure: Flow in ECAA
timeFrame: 24months
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMCU
state: Zuid Holland
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.