Aortic Stenosis Pre-Transcatheter Aortic Valve Replacement (TAVR) Procedure CT Scan
2018年7月31日 更新者：Medical University of South Carolina
Diagnostic Image Quality and Safety of Low-Volume, Low-Concentration, Iso-Osmolar Contrast Medium in the Computed Tomographic Workup of Patients Considered for TAVR
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.
研究概览
地位
完全的
条件
详细说明
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.
研究类型
介入性
注册 (实际的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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South Carolina
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Charleston、South Carolina、美国、29425
- Medical University of South Carolina
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 90年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinically Diagnostic CT Assessments
大体时间：up to 2 years
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Determine that restricting the contrast media volume to 60ml of 270 mgI/ml iodixanol or less generates clinically diagnostic CT assessments prior to TAVR.
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up to 2 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Image Quality
大体时间：up to 2 years
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Measure contrast media attenuation and determine diagnostic image quality within target structures in the aortic root and the ilio-aortic access route.
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up to 2 years
|
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Safety
大体时间：up to 2 years
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Evaluate safety and 30-day outcome of patients regarding survival, renal function, and adverse events (renal failure, dialysis, general morbidity).
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up to 2 years
|
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Long-term Follow-Up
大体时间：up to 4 years
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Determine procedural outcome of the TAVR procedure by longer-term patient follow-up after one and two years for device function, position, and paravalvular leakage.
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up to 4 years
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Joseph Schoepf, MD、Medical University of South Carolina
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年2月1日
初级完成 (实际的)
2017年9月25日
研究完成 (实际的)
2017年9月25日
研究注册日期
首次提交
2013年4月15日
首先提交符合 QC 标准的
2013年4月29日
首次发布 (估计)
2013年4月30日
研究记录更新
最后更新发布 (实际的)
2018年8月2日
上次提交的符合 QC 标准的更新
2018年7月31日
最后验证
2018年3月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.