NCT00415805已完成3 期
A Pilot, Open-label, Multicenter Intra-individual Comparison of Multihance and Vasovist for Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) of Renal Arteries
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity compared to DSA
研究概览
简要总结
This is an explorative small pilot study comparing two MRA contrast agents, one of which has been on the market for a few years and the other fairly new to the market. Since the study is explorative and designed to provide preliminary information for consideration for a future larger study, sample size is not based on statistical assumptions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Known or suspected renovascular disease based on one of the following criteria:
- •severe hypertension
- •hypertension refractory to standard therapy
- •abrupt onset of moderate to severe hypertension at age < 35 years
- •normalized blood pressure by an ACE inhibitor in a patient with moderate or severe hypertension
- •unexplained by stable elevation of serum creatinine > 2Mg/dL
- •positive findings for stenosis from another imaging modality
排除标准
- 未提供
研究组 & 干预措施
1
Experimental
干预措施: Multihance (Drug)
2
Active Comparator
干预措施: vasovist (Drug)
结局指标
主要结局
Sensitivity and specificity compared to DSA
时间窗: post dose
次要结局
- accuracy and predictive values; inter-reader agreement for diagnostic performance(post dose)
研究者
研究点 (1)
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