DyeVert™ System Use for Contrast Monitoring and Minimization in At-Risk Patients Undergoing Angiography Procedures: A Real-World Registry (DyeMINISH Registry)
试验速览
- 阶段
- 不适用
- 入组人数
- 10,000
- 试验地点
- 11
- 主要终点
- Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used
研究概览
简要总结
The purpose of this registry-based study is to evaluate the ongoing, real-world clinical performance and safety of commercially available DyeVert Systems during typical clinical use for patients undergoing coronary or peripheral angiography for diagnostic and/or interventional procedures.
详细描述
Contrast-induced acute kidney injury (CI-AKI) occurs in 3-19% of patients undergoing coronary angiography and is associated with increased morbidity, mortality, and healthcare costs. Patients with chronic kidney disease have greater odds of developing CI-AKI. Guidelines for CI-AKI prevention include screening for risk, volume expansion, and minimizing contrast media volume (CMV) to the patient during angiography; however, hospitals face barriers to implementation in the real-world setting and therefore consistent care delivery for at-risk patients remains a modern clinical challenge. DyeVert Systems provide real-time CMV monitoring and minimization during angiography procedures thereby reducing total CMV to the patient and total CMV relative to baseline renal function, two known risk factors for CI-AKI. The DyeMINISH Registry is designed to evaluate ongoing real-world clinical performance and safety of commercially available DyeVert Systems among a large, real-world population of patients undergoing coronary and peripheral angiography.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •DyeVert Group Patients: Patient underwent a diagnostic and/or interventional angiography procedure in which the DyeVert System was used in a majority of the case
- •Patient is willing and able to provide appropriate informed consent (if required)
排除标准
- •Required data was not collected or is not available
- •In the Investigator or Sponsor's opinion, the patient is not considered to be suitable
结局指标
主要结局
Evaluate incidence of adverse events associated with index cath lab procedures in which the DyeVert System was used
时间窗: Index procedure through 120 days post index procedure
Evaluate contrast media volume (CMV) threshold setting practices and contrast media (CM) usage during index cath lab procedures in which the DyeVert System was used
时间窗: Index procedure
次要结局
未报告次要终点
