Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Contrast to Noise Ratio
研究概览
简要总结
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •adult patients who are referred for coronary CTA for suspected or known coronary artery disease
排除标准
- •creatinine greater than 2.0
- •allergy to contrast media
- •patients under the age of 18
- •women who are pregnant or breast feeding
- •patients with cardiac arrhythmia will also be excluded
研究组 & 干预措施
Isovue 370
Isovue 370 is a contrast agent with increased iodine concentration.
干预措施: Isovue 370 (Drug)
Visipaque 320
Standard protocol is Visipaque 320.
干预措施: Visipaque 320 (Drug)
结局指标
主要结局
Contrast to Noise Ratio
时间窗: during scan, approximately 3 hours
Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Attenuation of the Ascending Aorta and Coronary Arteries
时间窗: during scan, approximately 3 hours
The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.
Image Quality
时间窗: during scan, approximately 3 hours
Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.
Motion Artifact
时间窗: during scan, approximately 3 hours
The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
次要结局
未报告次要终点