NCT00730964已完成4 期
A Post-marketing Surveillance Study of the Occurrence of Serious Adverse Reactions Among Patients Who Receive Optison in Routine Medical Practice
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,039
- 试验地点
- 1
- 主要终点
- The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.
研究概览
简要总结
This prospective surveillance trial will gather safety information for Optison when it is used in routine practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The subject is over 18 years old.
- •The subject has been scheduled for an Optison-enhanced echocardiography exam.
- •The subject has provided signed and dated informed consent.
排除标准
- •Known hypersensitivity to perflutren, blood, blood products or albumin.
研究组 & 干预措施
Phase 4
Other
Open Label
干预措施: Perflutren Protein-Type A Microspheres Injectable Suspension, United States Pharmacopeia (USP) (Drug)
结局指标
主要结局
The Frequency of Serious Adverse Reactions (SAR)'s Among Subjects Who Receive Optison (Causally Related to the Product)During Contrast Enhanced Echocardiography in Routine Clinical Practice.
时间窗: Within 24 hours post contrast administration
A Serious Adverse Reaction or (SAR) is considered causally related to the Optison product administered by the investigator. This reaction, should it occur, will be counted as a serious adverse reaction.
次要结局
- The Frequency of Overall Serious Adverse Events (SAE's) Among Subjects Who Receive Optison (Whether Related to the Product or Not) During Contrast Enhanced Echocardiography in Routine Clinical Practice.(Within 24 hours post contrast administration)
研究者
研究点 (1)
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