Development of Novel Imaging Markers Predicting the Progression of Abdominal Aortic Aneurysm Using 3D Computed Tomography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- Major adverse aorta-related events
研究概览
简要总结
Study purpose: This study will investigate anatomical factors associated with increased risk of major adverse aorta-related event and accelerated growth of abdominal aneurysm based on 3-dimensional analysis of CT images.
Study design: a multicenter single-arm prospective observational study.
Subject: patients with small abdominal aortic aneurysm with maximal diameter of 30-50 mm (n=323)
Methods: Patients diagnosed with small AAA based on CT will be enrolled after considering inclusion and exclusion criteria and prospectively followed clinically and with CT at 1 year.
Primary endpoint: Major adverse aorta-related events (death, aortic rupture, or aneurysm growth >0.4 cm per year) at 1 year
Secondary endpoints: 1) clinical events : death, aortic rupture, aneurysm growth >0.4 cm per year, surgical or endovascular repair 2) Changes in CT parameters of aneurysm: diameter, volume, wall shear stress
详细描述
Prospective single-arm multicenter registry
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •abdominal aortic aneurysm with maximum diameter of 30-50 mm
排除标准
- •Age <19 years
- •Serum Cr> 1.5mg/dL or eGFR<30 mL/min
- •Known allergic reactions to iodine contrast media
- •Women in pregnancy or women of childbearing age
- •Abdominal aortic aneurysms indicated for endovascular or surgical repair (symptomatic aneurysm or aneurysms with diameter >5cm)
- •Saccular type aneurysm, infected or inflammatory aneurysm
- •Combined aortic dissection
- •Aneurysms associated with genetic or connective tissue diseases (Marfan syndrome, Shprintzen-Goldberg syndrome, Loeys-Dietz syndrome, Takayasu's arteritis, Behcet's disease)
- •Past history of surgical or endovascular repair of aorta
- •Any surgical or endovascular repair planned within 1 year
- •Life expectancy < 1 year
结局指标
主要结局
Major adverse aorta-related events
时间窗: 1 year
Composite event of death, aortic rupture, or aneurysm growth \>0.4 cm per year
次要结局
- Number of clinical events(1 year)
- Change in CT parameter of aneurysm(1 year)