EUCTR2009-009421-29-GB进行中(未招募)1 期
on - invasive assessment of inflammatory burden in small abdominal aortic aneurysms: A USPIO - enhanced Magnetic Resonance Imaging (MRI) study - USPIO enhanced MRI of AAAs
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. All patients aged 18-90 years with small infra-renal AAAs (> 4.0 cm to < 5.5 cm), which are either newly detected or under regular surveillance and which are not being considered for surgery or endovascular treatment.
- •2.Female subjects must be of non-childbearing potential (post-menopausal females who have been amenorrheic >1 year, or pre-menopausal females with a documented hysterectomy or bilateral oophorectomy.
- •3. Signed written informed consent prior to beginning study related procedures (subject must understand the aims, investigational procedures and possible consequences of the study).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years)
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. History of atopy, asthma, allergic reaction to contrast materials.
- •2. Known and documented history of renal impairment
- •3. Known and documented history of haemochromatosis
- •4. Contraindication to MRI imaging including but not limited to:
- •a)Intracranial aneurysm clips (except Sugita) with an appropriate operative conformation
- •b)History of intra- orbital metal fragments that have not been removed by an MD
- •c)Pacemakers and non-MR compatible heart valves
- •d)Inner ear implants
- •e)History of claustrophobia in MR
- •5. Inability to give informed consent
研究者
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