NCT05828576

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: UMC Utrecht · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Extracranial Carotid Artery Aneurysm

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MRI	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.

Timeline

• Start date: 2023-03-30
• Primary completion: 2025-04-01
• Completion: 2025-04-01
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: Netherlands