The Assesment of Thrombotic Markers Utilizing Ionic Versus Non-Ionic Contrast During Coronary Angiography and Intervention (AToMIC) Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Thrombin Generation Test: Baseline
研究概览
简要总结
The aim of this study is to determine how two different types of iodinated contrast media (CM) agents, low-osmolar ionic ioxaglate and iso-osmolar non-ionic iodixanol, affect specific markers of thrombogenesis and platelet function in patients undergoing coronary angiography, and if the use of bivalirudin, a direct thrombin inhibitor used during percutaneous coronary intervention (PCI), affects any contrast-related changes in thrombogenesis and platelet function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (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
- •Patients must be more than 18 years of age
- •referred for coronary angiography and on dual anti-platelet therapy (aspirin and clopidogrel).
排除标准
- •on warfarin
- •on low molecular weight heparin within 12 hours of coronary angiography or unfractionated heparin with activated clotting time >150 at time of procedure -on cilostazol
- •on persantine
- •on non- steroidal anti-inflammatory medications (ibuprofen/motrin/advil, naproxen/aleve, indomethacin, sulindac, etodolac, diclofenac, celecoxib) within 72 hours of procedure
- •on prasugrel (not an exclusion criteria for ST-segment elevation myocardial infarction registry
- •undergoing coronary angiography via radial access
- •undergoing planned diagnostic coronary angiography only
- •unable to tolerate dual anti-platelet therapy
- •with known allergy to CM
- •received CM within 24 hours of coronary angiography
- •on dialysis
- •do not consent or are unable to give consent
- •are participating in another competing study.
研究组 & 干预措施
Ioxaglate Arm
干预措施: Ioxaglate (Drug)
Ioxaglate Arm
干预措施: Bivalirudin (Drug)
Iodixanol arm
干预措施: Iodixanol (Drug)
Iodixanol arm
干预措施: Bivalirudin (Drug)
结局指标
主要结局
Thrombin Generation Test: Baseline
时间窗: baseline
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.
Thrombin Generation Test: After Coronary Angiography
时间窗: 1 hour
The thrombin generation test uses recombinant tissue factor as a stimulus to initiate thrombin generation in plasma samples. The outcome from this assay is reported as area under the curve and represents the amount of thrombin in each sample. The curve is created by measuring the generated thrombin every 20 seconds from 0 to 95 minutes post stimulus.
次要结局
- Percent Change in Maximal Platelet Aggregation: Epinephrine(Baseline to 1 hour)
- Percent Change in Maximal Platelet Aggregation: ADP(1 hour)
- Percent Change in Maximal Platelet Aggregation: Arachidonic Acid(1 hour)