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

UMC Utrecht

Status: Enrolling

Conditions: Extracranial Carotid Artery Aneurysm

Treatments: Diagnostic Test: MRI

Study type: Observational

Funder types: Other

Identifiers

NCT05828576

22-781

Details and patient eligibility

About

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.

Full 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)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

50 participants in 1 patient group

ECAA patient

Description:

ECAA patient recieving conservative treatment

Treatment:

Diagnostic Test: MRI