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临床试验/NCT05758701
NCT05758701招募中4 期

Dual Energy CT Decreased IV Contrast Dose Imaging for TAVR

University of Maryland, Baltimore2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2023年9月19日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
164
试验地点
2
主要终点
Diagnostic Quality of Images

研究概览

简要总结

A standard polyenergetic CT (computed tomography) procedure utilizes 100 ml of iodinated contrast. A recent world-wide shortage of iodine based intravenous contrast has highlighted the need to search for alternative methods or doses. Reducing iodinated IV contrast dose can mitigate IV contrast supply shortages and enable significant cost savings for the radiology practice and hospital system. In addition, decreased IV contrast dose can potentially reduce the rate of acute kidney injury, specifically in patients with decreased renal function. The purpose of the study is to determine whether low IV contrast dose CT with monoenergetic reconstruction can be use for presurgical planning of transcatheter valve replacement (TAVR) procedure.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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 88 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • scheduled to receive TAVR abdominal CT

排除标准

  • cannot undergo CT scan
  • Allergy to intravenous contrast not controlled by steroids or benadryl

研究组 & 干预措施

Cohort 1

Experimental

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

干预措施: Iodinated Contrast Agent (Omnipaque) (Combination Product)

Cohort 1

Experimental

A cohort will be given a 1/3rd reduced dose of iodinated contrast agent (33 ml).

干预措施: Dual Energy CT (Device)

Cohort 2

Experimental

If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.

干预措施: Iodinated Contrast Agent (Omnipaque) (Combination Product)

Cohort 2

Experimental

If imaging with 1/3 dose is satisfactory, a second cohort with 1/4th the standard dosage (25 ml) will be assessed. If images are not satisfactory, contrast dose will be increased to 50 ml.

干预措施: Dual Energy CT (Device)

结局指标

主要结局

Diagnostic Quality of Images

时间窗: 18-24 months

5-point Likert Scale

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Vikas Kundra

Chief of Oncologic Imaging, Dept. of Radiology and Nuclear Medicine

University of Maryland, Baltimore

研究点 (2)

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