A Phase IV Pilot Study to Evaluate Kidney Damage Measured by Neutrophil Gelatinase-Associated Lipocalin (NGAL) as a New Bio-Marker in Patients With Normal 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
- 49
- 试验地点
- 1
- 主要终点
- Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
研究概览
简要总结
This is a pilot study, randomized, double-blind, parallel group comparison of two iodinated contrast agents used during percutaneous coronary intervention (PCI). All patients enrolled must have normal eGFR. Statistical summaries will be presented to analyse the various laboratory tests 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
- •Provides written Informed Consent and is willing to comply with protocol requirements;
- •Is at least 18 years of age;
- •Is scheduled to undergo a percutaneous coronary intervention and/or diagnostic coronary angiography.
- •Has documented estimated glomerular filtration rate [eGFR] ≥60 mL/min/1.73 m2 calculated with the MDRD formula within 72 hours prior to enrollment.
排除标准
- •Is a pregnant or lactating female.
- •Has a history of severe congestive heart failure
- •Has a history of hyperthyroidism
- •Has a history of hypersensitivity to iodinated contrast agents
- •Has unstable renal function
研究组 & 干预措施
IOPAMIDOL 370
干预措施: Non ionic contrast media comparator (Drug)
IODIXANOL 320
干预措施: Non ionic contrast media comparator (Drug)
结局指标
主要结局
Impact on the Trajectory of Serum and Urinary NGAL Following the Administration of Non-ionic Low Osmolar Contrast Media.
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 non-ionic low osmolar contrast media.
次要结局
未报告次要终点