Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Clinically Diagnostic CT Assessments
研究概览
简要总结
The purpose of this study is to evaluate contrast media volume, safety and 30-day outcome of patients after a computed tomography (CT) scan. The results of this study will help to determine the minimum volume of contrast material that can be used to ensure patient safety while not compromising diagnostic image quality in high-risk patients.
详细描述
The scholarly rationale for the study is to determine the feasibility of restricting the contrast media volume to 60ml of 270mg Iodine (mgI)/ml iodixanol or less to accomplish sufficient intravascular attenuation for comprehensive CT assessment prior to TAVR. The study will also evaluate the effects of contrast media administration on our subjects' kidney function by performing serum creatinine measurements at baseline, as well as at three days and thirty days after contrast media administration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be 18-90 years of age.
- •Subject must have been referred for a clinically indicated CT prior to TAVR.
- •Subject must provide written informed consent prior to any study-related procedures being performed.
- •Subject must be willing to comply with all clinical study procedures.
排除标准
- •Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
- •By testing (serum or urine βHCG) within 24 hours before contrast agent administration, or
- •By surgical sterilization, or
- •Post menopausal, with minimum one (1) year history without menses.
- •Subject has an acute psychiatric disorder or is cognitively impaired.
- •Subject is using or is dependent on substances of abuse.
- •Subject is unwilling to comply with the requirements of the protocol.
- •Subject has previously entered this study.
- •Subject has an allergy against iodinated contrast agents.
- •Subject is in acute unstable condition.
研究组 & 干预措施
Low-volume, Low-concentration contrast (Visipaque 270) CT scan
An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material.
干预措施: Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan (Drug)
结局指标
主要结局
Clinically Diagnostic CT Assessments
时间窗: up to 2 years
Determine that restricting the contrast media volume to 60ml of 270 mgI/ml iodixanol or less generates clinically diagnostic CT assessments prior to TAVR.
次要结局
- Image Quality(up to 2 years)
- Safety(up to 2 years)
- Long-term Follow-Up(up to 4 years)