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临床试验/NCT04832633
NCT04832633已完成不适用

The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography

Mackay Memorial Hospital1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
1
主要终点
Enhancement of the aorta

研究概览

简要总结

Background: The contrast time-enhancement profiles of pulmonary artery (PA) and the aorta differ by using computed tomography (CT) angiography. Our purpose is to identify the optimal CT protocol for assessment of both vessels in one-time CT scan.

Methods: The investigators prospectively enrolled 101 cases of CT angiography with suspicion of pulmonary embolism or aortic dissection in our center from 2018 to 2020. Forty cases receiving traditional two-time CT scans were collected retrospectively from 2015 to 2018.

The investigators designed four groups: test bolus (TB) I, II and bolus-tracking (BT) I, II. The enhancement of the both vessels and the radiation dose of these four groups were collected. Traditional group was separated into traditional PA scan and traditional aorta scan. Data analyzed among the BT groups and the traditional groups were performed.

详细描述

Patients All cases with suspicion of PE or AD referred for CTA in our hospital between March 2018 and February 2020 had been reviewed. Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study. The investigators finally enrolled and analyzed 101 cases of CTA. The collected data included age, sex, blood pressure, body mass index (BMI), Hounsfield unit (HU) at bifurcation of PA, HU at the descending aorta with the same level of PA bifurcation, time to peak enhancement, and radiation dose. This study had been approved by the institutional review board in our hospital. All patients signed informed consent.

In addition, forty cases with suspicion of PE or AD performing traditional two-time CT scans were reviewed retrospectively. For controlling the dose of contrast media, the two-time CT scans in our hospital were performed with single 80ml contrast media injection at 3ml/sec, followed by 20ml normal saline injection at 3ml/sec. The CT PA angiography was performed when the density of the PA achieved baseline PA density plus 150 HU during tracking scans, followed immediately by the CT aortogram. The investigators compared the experimental groups and traditional groups.

Experimental designs of contrast media injection After the contrast injection, the contrast media goes to the right heart via peripheral veins and then the contrast is pumped out to the PA. The interval from contrast injection to the peak enhancement of PA is defined as P seconds. After pulmonary circulation, the contrast media travels through the pulmonary veins, the left atrium, and the left ventricle and contracts into the aorta. The interval from contrast injection to the peak enhancement of aorta is defined as A seconds. Afterward, the contrast media starts a new cycle of systemic circulation.

Based on the published data, for the pulmonary artery, adequate attenuation is known to be greater than 180 HU, and for the aorta, sufficient attenuation is known to be greater than 200 HU. However, the requirement of vascular enhancement for diagnosing PE is high because the size of the PA is significantly tapering and the thrombus in the distal PA branches will be vague if the enhancement of the PA is not vivid. Therefore, insufficient enhancement of the PA restricts the ability to diagnose PE. The investigators design a biphasic contrast media injection protocol, including a low rate(2ml/s) first phase injection and high rate(3ml/s) second phase injection, followed by high rate(3ml/s) normal saline injection. The first phase injection is kept for (A - P) seconds and the second phase injection is kept until the rest contrast media is completely injected. Theoretically, when the start time of the scan is at the A seconds, the first phase contrast media is about to significantly enhance the aorta, though the peak time and peak enhancement will not be optimal because the time intervals are calculated on the basis of high rate (3ml/s) injection. On the other hand, the second phase contrast media will maximally enhance the PA at the same time because the second phase contrast media has been injected for P seconds [A-(A-P)=P].

The pre-diagnostic axial CT images were set at the level of the PA bifurcation using 10ml test bolus contrast media injection at the 3ml/s rate. Radiology technologists in our team placed circular region of interest (ROI) within the areas of PA bifurcation and the descending aorta at the same level. The CT densities were collected and demonstrated the time-enhancement data. The peak enhancement time for the PA was chosen as P seconds and that for the aorta as A seconds.

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 (Participant)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All cases with suspicion of pulmonary embolism or aortic dissection referred for CT angiography in our hospital

排除标准

  • •Those cases with known allergic history, poor renal function (creatinine level>1.5 mg/dl), pregnant women or age less than twenty years old were excluded from the study.

研究组 & 干预措施

test bolus(TB) I

Experimental

We use the TB method with biphasic injection, followed by the saline flush. Initially, we inject the 10 ml of test contrast media with a velocity of 3ml/s and apply the ROI at the bifurcation of PA and descending aorta at the same level. The dynamic curve demonstrates the time to peak enhancement of P second and A second. The first phase of contrast media injection uses a velocity of 2ml/s and the volume of contrast is measured as 2ml/s multiply (A-P) second. The second phase of contrast media injection uses a velocity of 3ml/s and the volume of contrast media is 70ml minus the amount of first phase injection. The total volume of the contrast media is 80ml, including the 10ml for pre-diagnostic test bolus images. We performed the saline flush following the administration of the contrast media with 20 ml normal saline. The start time of the diagnostic scan is at the A second.

干预措施: Different contrast media injection methods (Diagnostic Test)

test bolus(TB) II

Experimental

This group is similar to the TB I. However, we use the lesser contrast media in the second phase of injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus the amount of first phase injection. The total volume of the contrast media is 70 ml, also including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The start time of the diagnostic scan is at the A second as well.

干预措施: Different contrast media injection methods (Diagnostic Test)

bolus-tracking(BT) I

Experimental

Initially, 10ml of test contrast media was administrated but no calculation was performed for these pre-diagnostic test bolus images in this group. Unlike the TB method, we use 10 seconds as the fixed interval of (A-P) in this group. The first phase of contrast media injection uses a velocity of 2ml/s and thus the volume of contrast is 20ml. The second phase of contrast media injection is administered with a velocity of 3ml/s and the volume of the contrast media is 70ml minus 20ml. The total volume of the contrast media is 80 ml. The following saline flush uses 20 ml of normal saline. The tracking scan started after contrast injection was initiated for 15 seconds. The ROI is placed in the descending aorta at the same level of PA bifurcation and the diagnostic CT scan is triggered when the density in the ROI achieves the baseline density plus 150HU.

干预措施: Different contrast media injection methods (Diagnostic Test)

bolus-tracking(BT) II

Experimental

This group is similar to the BT I. The first phase of injection is the same as the BT I group. We use lesser contrast media in the second phase of contrast injection. The second phase of contrast media injection is applied with a velocity of 3ml/s and the volume of the contrast media is 60ml minus 20ml. The total volume of the contrast media is 70 ml, including the 10ml for pre-diagnostic test bolus images. The following saline flush uses 30 ml of normal saline. The protocol for triggering diagnostic CT scan is the same as that in BT I.

干预措施: Different contrast media injection methods (Diagnostic Test)

结局指标

主要结局

Enhancement of the aorta

时间窗: Through study completion, an average of 1 year

The enhancement of the aorta at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the aorta. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the aorta among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant.

Enhancement of the pulmonary artery

时间窗: Through study completion, an average of 1 year

The enhancement of the pulmonary artery at the level of pulmonary artery bifurcation will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows better enhancement of the pulmonary artery. The statistical analysis is the following: A one-way analysis of variance (ANOVA) test was used for comparing the average enhancement of the pulmonary artery among the four different groups. If the test of homogeneity of variances was not statistically different, Scheffe method was used for post hoc analysis. On the contrary, Games-Howell method was used for post hoc analysis. A p value of ≤0.05 was considered statistically significant.

次要结局

  • Radiation dose(Through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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