NCT00310544已完成2 期
Multicenter, Single-blind, Randomized, Intraindividual Study of the Safety and Efficacy of Magnevist Gadopentetate Dimeglumine (Magnevist® Injection) at 0.1 and 0.2 mmol/kg for the Depiction of Delayed Enhancement in Patients With Documented Myocardial Infarction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 73
- 主要终点
- Quantitative measurement of the total area of delayed enhancement
研究概览
简要总结
The purpose of this study is to determine the dose of drug which is most effective in the delineation of dead heart muscle.
详细描述
This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 8 weeks post-documented myocardial infarction (heart attack)
排除标准
- •History of radiation therapy to the chest
- •Clinically unstable
- •Any contraindication for MRI
研究组 & 干预措施
Arm 2
Experimental
干预措施: Magnevist (Gadopentetate dimeglumine, BAY86-4882) (Drug)
Arm 1
Experimental
干预措施: Magnevist (Gadopentetate dimeglumine, BAY86-4882) (Drug)
结局指标
主要结局
Quantitative measurement of the total area of delayed enhancement
时间窗: 30 min post injection
次要结局
- Presence of delayed enhancement(At 5,10 and 20 minutes post injection)
- Wall motion endpoints(Pre-injection)
- Safety(From baseline to 24h follow-up of second imaging)
- Quantitative measures of area of delayed enhancement and signal intensities(At 5, 10 and 20 minutes post injection)
- Semiquantitative measures of area of delayed enhancement(At 5, 10, 20 and 30 minutes post injection)
研究者
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