NCT00845702终止3 期
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Guerbet
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Percent of Non Assessable Renal Artery Segments
研究概览
简要总结
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.
详细描述
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Male or female, aged more than 18 years,
- •Strongly suspected of having renal arterial disease,
- •Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,
排除标准
- •Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²),
- •Contraindication to MRI,
- •Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,
研究组 & 干预措施
Dotarem
Experimental
Each subject will receive one injection of Dotarem 0.2 ml/kg.
干预措施: Gadoterate meglumine (Dotarem) (Drug)
Time Of Flight Magnetic Resonance Angiography
Other
Each subject undergo a TOF MRA
干预措施: Time of Flight Magnetic Resonance Angiography (Other)
结局指标
主要结局
Percent of Non Assessable Renal Artery Segments
时间窗: 1 to 7 days
For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared
次要结局
未报告次要终点
研究者
研究点 (1)
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