NCT00479024已完成不适用
CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY
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
- 入组人数
- 294
- 试验地点
- 1
研究概览
简要总结
To determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as >25% increase in SCr or >25% increase in cystatin C).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •(from previous CARE trial)
- •• Screening eGFR between 20 and 59 mL/min/1.73m2
- •Baseline SCr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration
- •At least one post dose blood sample available
- •Received randomized contrast agent
- •Underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by PCI was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study
- •Provides written Informed Consent and is willing to comply with protocol requirements;
- •Was included in the patient list provided by Bracco;
- •At least 1 year has passed since the patient's participation ended in the original CARE trial, as determined from the list provided by Bracco
排除标准
- •• Screening eGFR outside the range of 20 and 59 mL/min/1.73m2
- •Unstable kidney disease or requiring dialysis upon enrollment
- •Prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function
- •Did not receive randomized contrast agent per CARE protocol
- •Did not undergo a cardiac angiography procedure per CARE protocol
研究组 & 干预措施
observation
patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients
干预措施: iodinated contrast agent (Drug)
研究者
研究点 (1)
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