NCT01206257已完成不适用
This is an International, Prospective, Non-interventional Study, Company Sponsored, Multi-center Study. Patients Undergo Coronary Angiography or PCI Procedure With Ultravist. The Primary Objective is to Evaluate the Safety and Tolerability.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 17,513
- 主要终点
- Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
研究概览
简要总结
This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients who receive Ultravist® for coronary angiography or PCI can be included in the study
排除标准
- •Patients who are or are suspected in pregnancy or nursery
- •Patients with the contraindications for Ultravist
- •Patients with the contraindications for cardiac catheterization
研究组 & 干预措施
Group 1
干预措施: Iopromide (Ultravist, BAY86-4877) (Drug)
结局指标
主要结局
Evaluation of the safety and tolerability of Ultravist® in patients Undergoing cardiac catheterization.
时间窗: 12 months
次要结局
- Estimation of the image quality of Ultravist®(12 months)
研究者
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