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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECAA patient | ECAA patient recieving conservative treatment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMCU | Recruiting | Utrecht | South Holland | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26116488 | Result | 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. | |
| 32115417 | 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. |
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| 24months |
| 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. | 24months |
| Silent brain lesions | To investigate the presence and localisation of silent brain lesions in ECAA patients | 24months |
| 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. | 24months |
| 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. | 24months |
| 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. | 24months |
| 33727406 | 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. |
| 23867200 | 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. |