Comparison of Contrast Agents During CT Angiography
关键词
抽象
描述
CTA infusion is administered using a 5 ml/sec IV iodinated contrast infusion. 50-70 ml of iodinated contrast is used for the scan depending on the patient's body habitus. The total contrast dose must not exceed 70 ml. An automated bolus tracking feature (SmartPrep, GE Healthcare, Milwaukee, USA) is used to judge contrast bolus arrival and optimize image quality. Patients will be asked to hold their breaths during scanning for up to 10 seconds. A Field of View (FOV) of 25 cm is adjusted to include the heart from below the carina to just below diaphragm. The aorta will be included in the FOV to exclude aortic pathology (ie. dissection, aneurysm, etc.). For patients in sinus rhythm, prospective ECG gating centered at 75% of the R-R interval is used while those in Atrial fibrillation or HR >65 despite oral and IV medications, a retrospective gating is used. The following parameters are used Tube voltage = 100-120kV (based on body habitus), tube current = 400 mA, gantry rotation speed = 0.35 seconds, slice thickness = 0.625 mm, rows = 64, coverage = 128-160 mm.
Estimated radiation dose is = 2-5 mSv dependent on BMI, cardiac height and heart rate. A post acquisition software (Adaptive Statistical Iterative Reconstruction, GE healthcare, Milwaukee, USA) is used to reduce pixel noise standard deviation (noise) by 30 percent and allows for reduced mA in the acquisition while still yielding diagnostic images, thereby reducing total dose required. At the conclusion of each acquisition, technologists collect a survey of patient satisfaction quantifying side effects of different contrasts: flushing, headache, nausea, and pain at injection site as mild, moderate or severe.
Advantage Workstation 4.6 software (GE healthcare, Milwaukee, USA) is used for post acquisition processing. Readers, who are blinded to the type of contrast media used, assess image quality by measuring contrast enhancement in aorta, LV myocardium, left main, proximal Left Anterior Descending artery, proximal and distal Right Coronary arteries. Subjects with coronary artery bypass graft and stents are excluded. Heart rate (HR) variability during the scan is also evaluated. A comparison of the degree of contrast enhancement of the coronary lumen as well as the differences for each of the four contrast agents will be measured and reported, stratified by 100 kVp and 120 kVp acquisition. The image quality of 17 coronary artery segments will be graded by two cardiologists in consensus with the use of a four-point scale (1= excellent, 2=good, 3=fair , 4= poor enhancement) blinded to contrast agent administration.
Statistical Analysis:
All analysis is conducted using SPSS 18.0 for window (SPSS Inc., Chicago, IL, USA). Comparisons between groups are performed using a Student t-test for continuous variables with normal distributions and the Mann-Whitney U test for continuous variables with non-normal distributions. Categorical variables were analyzed by means of χ2 analysis. Correlation between minimum HR and maximum HR was calculated with the Pearson correlation coefficient. The Cochran-Mantel-Haenszel test was used for analyzing the difference in visual quality between two groups.
日期
最后验证: | 02/28/2017 |
首次提交: | 02/13/2012 |
提交的预估入学人数: | 02/15/2012 |
首次发布: | 02/16/2012 |
上次提交的更新: | 01/30/2018 |
最近更新发布: | 02/28/2018 |
首次提交结果的日期: | 03/09/2017 |
首次提交质量检查结果的日期: | 01/30/2018 |
首次发布结果的日期: | 02/28/2018 |
实际学习开始日期: | 12/31/2011 |
预计主要完成日期: | 12/31/2012 |
预计完成日期: | 12/31/2012 |
状况或疾病
干预/治疗
Diagnostic Test: contrast agent
相
手臂组
臂 | 干预/治疗 |
---|---|
Active Comparator: Iodixanol 320 group 1 will receive iodixanol 320 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography | |
Active Comparator: iohexol 350 group 2 will receive iohexol 350 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography | |
Active Comparator: iopamidol 370 group 3 will receive iopamidol 370 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography | |
Active Comparator: iodixanol 270 group 4 will receive iodixanol 270 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: Subjects may be included in the study if they meet all of the following criteria: 1. The subject is over 18 years old. 2. Subject scheduled to undergo a contrast-enhanced CCTA examination 3. The subject has no contra-indication to receiving iodinated contrast administration (allergy, renal insufficiency). 4. The subject has provided signed and dated informed consent Exclusion criteria: Subjects must be excluded from participating in this study if they meet the following criteria: 1. Subjects have known contra-indication to contrast administration: - Renal insufficiency as defined by GFR < 50 - Known contrast allergy 2. Pregnant or possibly pregnant subjects will be excluded -Women of childbearing potential will undergo urine pregnancy test prior to CT scanning. |
结果
主要结果指标
1. Image Quality of the CT Scans Using Different Contrast Agents [1 year]