Minimizing cOntrast utiliZAtion With IVUS Guidance in coRonary angioplasTy: The MOZART Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Total Volume of Iodine Contrast Used During Procedure
研究概览
简要总结
This study tests the hypothesis that ultrasound-guided PCI reduces contrast volume during the procedure.
详细描述
Contrast-induced acute kidney injury (CI-AKI) is an important adverse effect of percutaneous coronary interventions. Despite various efforts, very few preventive measures have been shown effective in reducing its incidence. The final volume of contrast media utilized during the procedure is a well-known independent factor affecting the occurrence of CI-AKI.
Intravascular ultrasound (IVUS) has been largely used as an adjunctive diagnostic tool during percutaneous coronary intervention (PCI). When fully explored, IVUS provides precise information for guiding the PCI strategy. IVUS allows accurate vessel and lesion sizing, determination of plaque calcification (and the need for pre-stent plaque preparation), assessment of post-stent results (including edge dissections and residual lesion, as well as stent underexpansion or incomplete apposition). Therefore, IVUS has the potential to reduce the utilization of contrast media during PCI.
In the present study, we hypothesize that IVUS guidance is associated with a significant reduction in the volume of contrast media during PCI, in comparison to standard angiography-guided intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Written informed consent
- •Age >=18 years
- •Coronary artery disease scheduled for percutaneous intervention
- •Technical feasibility for intravascular ultrasound to guide coronary angioplasty
- •Increased risk for contrast-induced acute renal failure (e.g. age > 80 years, female gender, diabetes, urgent or emergent procedure priority, diabetes, congestive heart failure, increased baseline serum creatinine, decreased calculated or measured creatinine clearance, intra-aortic balloon pumping, previous renal transplantation or single kidney)
排除标准
- •Anticipated technical impossibility for intravascular ultrasound
- •Unknown baseline renal function
- •Baseline end-stage renal failure needing dialysis
- •Acute renal failure with dynamic change in renal function at the time of index procedure
- •Iodine contrast administration <= 72 prior to index procedure
- •Known allergy to iodine contrast
结局指标
主要结局
Total Volume of Iodine Contrast Used During Procedure
时间窗: Day 1
Total volume of iodine contrast administered during the index procedure.
次要结局
- Major Adverse Cardiac Events(30 days and 6 months)
- Incidence of Contrast-induced Nephropathy(7 days)
研究者
Pedro A. Lemos
Professor of Medicine
InCor Heart Institute