4D-MRI Morphological Study of Local Growth in Cerebral Aneurysms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- CHU de Reims
- 入组人数
- 281
- 试验地点
- 1
- 主要终点
- Evolution of the shape of the aneurysm
研究概览
简要总结
An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. The objective of this project is to utilize MRI, a routine non-invasive examination for detecting and following up aneurysms, to identify visually and quantitatively an aneurysm growth and relevant biomarkers that can predict the risk of aneurysm development.
详细描述
An intracranial aneurysm is defined as a malformation of the cerebral arteries, which is characterized by a focal dilatation of the arterial wall.
The prevalence of intracranial aneurysms in the general population is estimated to be between 3% and 6%, as reported in the literature. Although the rupture rate is relatively low, at approximately 1-2% per year per aneurysm, this risk is increased if the aneurysm is growing. The morbi-mortality rates associated with meningeal or subarachnoid hemorrhage are high, with an estimated 60% mortality rate within three months and 30% of patients remaining permanently disabled. It is therefore imperative to monitor the evolution of aneurysms in order to assess the risk of complications and guide therapeutic decisions.
The mechanism(s) of aneurysm formation and growth remain unknown. Aneurysms form in a zone of weakness in the artery wall as a result of hemodynamic variations.
Methods of risk stratification and therapeutic planning (endovascular treatment (coil) or surgical treatment (clip)) are currently based solely on empirical and statistical parameters such as the size or shape of the aneurysm, the patient's smoking habits or alcoholism.
The fundamental principle underlying the treatment of cerebral aneurysms with the objective of reducing the risk of long-term rupture is the exclusion of the aneurysm from the arterial circulation. This confirm the impact of hemodynamics on the risk of aneurysm rupture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Patients with one or more unruptured intracranial aneurysms followed up at the participating center. Patients may have other ruptured and/or treated aneurysms
- •Patient older than 18 years
- •Patient consenting to participate to the study
- •Patient enrolled in the national healthcare insurance program
排除标准
- •Patients who have already received surgical or endovascular treatment for all their aneurysm(s), or who are due to receive such treatment in less than 2 months.
- •Patients with only ruptured aneurysm(s)
- •Patients with arteriovenous malformations (treated or untreated)
- •Patients with a contraindication to MRI
- •Patients with an allergy to one of the contrast agents (Iodixanol, Gadoteric acid)
- •Pregnant or breast-feeding patients
- •Patients protected by law.
研究组 & 干预措施
Patients with unruptured and untreated aneurysms
Patients in radiology for the first diagnostic evaluation or the follow-up of unruptured and untreated aneurysms.
干预措施: Additional 4D Flow MRI or additional 4D Flow sequence (Other)
结局指标
主要结局
Evolution of the shape of the aneurysm
时间窗: At 3 years
Millimetric quantification of the three-dimensional evolution of the shape of the aneurysm sac, calculated using a computer algorithm
次要结局
未报告次要终点