NCT00625365已完成4 期
CARES (Contrast EchocArdiography REgistry for Safety Surveillance): A Prospective, Phase IV, Open-Label, Nonrandomized, Multicenter, Surveillance Registry Study to Evaluate the Safety of DEFINITY® in Clinical 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
- 1,060
- 试验地点
- 16
- 主要终点
- The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
研究概览
简要总结
The purpose of this registry study is to gather safety information on the current clinical use of and the safety of DEFINITY®
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
DEFINITY® (Perflutren Lipid Microsphere)
Other
Patients who had undergone unenhanced echocardiography yielding suboptimal images and who were determined by the Principal Investigator to require DEFINITY-enhanced echocardiography
干预措施: DEFINITY® (Drug)
结局指标
主要结局
The Number and Percentage of Patients With Death or Life Threatening Cardiopulmonary Events Occurring Following Definity Administration
时间窗: during or within 30 minutes of administration
次要结局
- Serious Adverse Events(Through 24 hours)
- Adverse Events(Through 24 hours)
研究者
研究点 (16)
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