EUCTR2012-002448-25-GB进行中(未招募)1 期
Magnetic Resonance Imaging Using Ultrasmall Superparamagnetic Particles of Iron Oxide in Patients Under Surveillance for Abdominal Aortic Aneurysms to Predict Rupture or Surgical Repair: the MA3RS Trial - MAR3S Trial
niversity of Edinburgh0 个研究点目标入组 342 人开始时间: 2012年8月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 342
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. Abdominal aortic aneurysms measuring =40mm in anteroposterior diameter on ultrasound scanning. 2. Age =40 years. Patients with abdominal aortic aneurysms less than 40 years may have a connective tissue disorder and a different aetiology to their disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 115
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 234
排除标准
- •1. Patients expected to undergo imminent elective or emergency surgical or endovascular repair. 2. Contraindication to magnetic resonance imaging scanning identified from magnetic resonance imaging safety questionnaire, which includes but not limited to: - intracranial aneurysm clips (except Sugita) or other metallic objects - history of intra-orbital metal fragments that have not been removed - pacemakers, implantable cardiac defibrillators and non-MR compatible heart valves - inner ear implants - history of claustrophobia in MR - allergy to MRI contrast enhancement agent 3. Patients refusing or unable to give informed consent 4. Woman with child-bearing potential will not be enrolled into the trial (woman who have experienced menarche, are pre-menopausal, have not been sterilised or who are currently pregnant). 5. Intercurrent illness including patients with a systemic inflammatory disorder or underlying malignancy (life expectancy < 2 years). 6. Renal dysfunction (eGFR =30 mL/min/1.73m2). 7. Polycythemia. 8. Contraindication to ferumoxytol (evidence of iron overload, known hypersensitivity to ferumoxytol or its components or anaemia not caused by iron deficiency).
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