Evaluation of a Single Intravenous Injection of Magnevist (SH L 451 A) at 0.1 mmol/kg and 0.2 mmol/kg in Contrast-enhanced 3D-Magnetic Resonance Angiography in Patients With Arterial Disease in the Abdominal to Leg Regions in the Ability of Detecting of Vessel Abnormalities
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 12
- 主要终点
- Diagnostic ability
研究概览
简要总结
The objective of the study was to compare the efficacy of Magnevist (SH L 451 A) at doses of 0.1 mmol/kg and 0.2 mmol/kg in contrast-enhanced 3D-Magnetic Resonance Angiography in three regions (abdominal, femoral, and leg regions) for visualization of arteries, evaluating 179 not assessable: caused by contrast media in the evaluation of structural abnormalities. Magnevist (SH L 451 A) was administered intravenously in a crossover design in patients with arterial disease in the abdominal to leg regions. The safety of the 0.2 mmol/kg dose was also assessed.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are scheduled to undergo contrast-enhanced 3D-Magnetic Resonance Angiography
排除标准
- •Patients with an ankle brachial pressure index (ABPI) of 0.3 or less
- •Patients with allergy to contrast media
- •Patients with serious hepatic impairment
- •Patients with serious renal impairment
研究组 & 干预措施
Arm 1
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) (Drug)
Arm 2
干预措施: Gadopentetate dimeglumine (Magnevist, BAY86-4882, SH L 451A) (Drug)
结局指标
主要结局
Diagnostic ability
时间窗: MRI image in blinded read
次要结局
- Visibility(MRI image in blinded read)
- Diagnostic confidence(MRI image in blinded read)
