Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin as New Biomarker in Patients With Moderate Fall in eGFR Undergoing Percutaneous Coronary Intervention With IOPAMIDOL Injection 370 or IODIXANOL 320
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 4
- 主要终点
- Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
研究概览
简要总结
To compare Iopamidol injection 370 and Iodixanol 320 in evaluating Neutrophil Gelatinase-Associated Lipocalin (NGAL) in patients with moderate fall in eGFR
详细描述
This is a pilot study having a randomized, double-blind parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have eGFR greater than or equal to 30 mL/min and less than or equal to 59 mL/min. Statistical summaries will be presented to analyze the various lab tests results for the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 18 years of age and provides informed consent
- •Scheduled to undergo percutaneous coronary intervention
- •Documented pre-dose Estimated glomerular filtration rate (eGFR) of greater than or equal to 30 mL/min/1.73 m squared and less than or equal to 59 mL/min/1.73 m squared
排除标准
- •Pregnant or lactating females
- •Severe congestive heart failure
- •History of hyperthyroidism;
- •Unstable renal function
- •Emergency PCI
- •History of hypersensitivity to iodinated contrast agents
- •Receiving diuretics to prevent acute renal injury
研究组 & 干预措施
Iopamidol
Non-ionic low-osmolar iodinated contrast media
干预措施: Iopamidol (Drug)
Iodixanol
Non-ionic iso-osmolar iodinated contrast media comparator
干预措施: Iodixanol-320 (Drug)
结局指标
主要结局
Impact on the Trajectory of Serum and Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) Following Administration
时间窗: Baseline and 2, 4, 6, 24, 48,and 72 hours post-dose
Mean change from baseline values for serum NGAL at 2,4,6,24,48, and 72 hours, and urine NGAL at 2,4,6,24, and 48 hours following the administration of contrast media.
次要结局
未报告次要终点