Seeking the Link Between Extracranial Carotid Artery Aneurysms and Small Vessel Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Small vessel disease in ECAA patients
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Small vessel disease in ECAA patients
时间窗: 2023-2025
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
次要结局
- Small vessel disease in ECAA patients in time(24months)
- Small vessel disease uni/bilateral(24months)
- Aneurysm morphology.(24months)
- Silent brain lesions(24months)
- Flow in ECAA(24months)