NCT01655290已完成2 期
Single Dose Gadobutrol in Comparison to Single Dose Gadobenate Dimeglumine for Magnetic Resonance Imaging of Chronic Myocardial Infarction at 3 Tesla
Technical University of Munich2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2012年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Efficacy (contrast-to-noise ratio)
研究概览
简要总结
This study aims at evaluating the diagnostic efficacy of Gadobutrol versus Gadobenate dimeglumine at similar dose of 0.1mmol/kg for assessment of myocardial infarction by delayed enhancement cardiac Magnetic Resonance Imaging
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of myocardial infarction
- •Age ≥ 18 years and ≤ 80 years
- •Informed consent
- •Male patients as well as female patients using contraceptives
排除标准
- •Patients with a heart pacemaker, with magnetic material or other magnetic implants.
- •Renal failure (GFR <30ml/min)
- •Patients with known allergy to a Gadolinium-containing contrast agent
- •Drugs or alcohol addiction, dementia
结局指标
主要结局
Efficacy (contrast-to-noise ratio)
次要结局
未报告次要终点
研究者
研究点 (2)
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