Advanced MRI in AAA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Wall shear stress (WSS)
研究概览
简要总结
This study aims to determine whether advanced MRI sequences can provide robust and clinically relevant information about abdominal aortic aneurysms (AAAs). The MRI sequences will study outcomes related to blood flow inside AAA, microvasculature of the AAA vessel wall and intraluminal thrombus inside AAA.
Robustness of these MRI sequences will be determined with testing of feasibility and reproducibility. Clinical relevance will be assessed by studying the association between the primary outcomes and disease severity. Disease severity will be expressed by AAA diameter.
It is our hypothesis that these parameters are significantly related to disease severity and may therefore be future markers of disease progression.
详细描述
This prospective study evaluates the feasibility, reproducibility and clinical relevance of MRI sequences in adults with an abdominal aortic aneurysm (AAA).
The MRI sequences and their primary outcomes are:
- Four-dimensional (4D) flow MRI and wall shear stress (WSS)
- Dynamic Contrast-Enhanced (DCE) MRI and kinetic transport constant (Ktrans)
- T1 and T2 mapping (T1 and T2 relaxation times)
Feasibility is tested by the production of high-quality images that enable calculation of the primary outcomes. Reproducibility is tested by calculating interscan, intra- and interobserver variability. Clinical relevance is tested by assessing the association between primary outcomes and disease severity which is expressed by AAA diameter
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Adult patients (≥ 18 years of age)
- •Abdominal aortic aneurysm with a maximal aneurysm diameter of at least 30 mm
排除标准
- •Contra-indications for MRI
- •Severely reduced renal function (eGFR < 30)
- •Previous allergic reaction to intravenous contrast agents
- •Suprarenal AAA
- •Pararenal AAA
- •Previous aneurysm repair
- •Inflammatory aneurysm
- •Mycotic or other infectious aneurysm
- •Vasculitis
- •Connective tissue disease
结局指标
主要结局
Wall shear stress (WSS)
时间窗: Time of MRI scan
Primary outcome of 4D flow MRI
T1 relaxation time
时间窗: Time of MRI scan
Primary outcome of T1 mapping
Kinetic transport constant (Ktrans)
时间窗: Time of MRI scan
Primary outcome of DCE-MRI
T2 relaxation time
时间窗: Time of MRI scan
Primary outcome of T2 mapping
次要结局
- Area under the curve of contrast uptake(Time of MRI scan)
- Wash-in slope(Time of MRI scan)
- Peak flow velocity inside the aneurysm(Time of MRI scan)
- Location of peak wall shear stress(Time of MRI scan)
- Peak enhancement ratio(Time of MRI scan)
- Flow velocity at aneurysm entrance(Time of MRI scan)
- Oscillatory shear index(Time of MRI scan)
- Reverse reflux rate constant (kep)(Time of MRI scan)
- Mean transit time (MTT)(Time of MRI scan)
- Flow patterns(Time of MRI scan)
- Time to peak (TTP)(Time of MRI scan)
研究者
Ron Balm
prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)