Enhancement of Aorta and Pulmonary ArteryNCT04832633
The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography
A study testing Different contrast media injection methods in people with Enhancement of Aorta and Pulmonary Artery and Radiation Exposure, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Enhancement of Aorta and Pulmonary Artery, Radiation Exposure
- What is being tested?
- Different contrast media injection methods
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 28 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All cases with suspicion of pulmonary embolism or aortic dissection referred for CT angiography in our hospital
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
The investigators designed four groups, including two groups using the test bolus (TB) method and two groups using the bolus-tracking (BT) method. The two TB groups were different at the total amount of contrast media with 80ml and 70ml respectively. The P and A seconds were calculated from the pre-diagnostic images and the start time of scan was fixed at A seconds. Based on the results of initial 22 cases in the two TB groups, the mean interval between P and A seconds was approximately 9.5 seconds. Therefore, we roughly assumed the A-P interval in most cases was about 10 seconds and designed the two BT groups with a fixed 10-second first phase contrast media injection time. The start time of scan was based on the tracking method when the descending aorta at the PA bifurcation achieved the baseline density plus 150 HU. The tracking scan started after contrast injection was initiated for 15 seconds. The two BT groups were also different at the total amount of contrast media with 80ml and 70ml respectively, including the 10ml for the pre-diagnostic images in order to have the same condition before the diagnostic CT images.
Details of the four experimental groups:
- TB I: The investigators use the TB method with biphasic injection, followed by the saline flush. Initially, the investigators 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. The investigators 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.
- TB II: This group is similar to the TB I. However, the investigators 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.
- BT I: 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, the investigators 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.
- BT II: This group is similar to the BT I. The first phase of injection is the same as the BT I group. The investigators 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.
CT scan technique and contrast medium administration CT was performed using a 320-MDCT (Canon Aquilion PRIME CT scanner, Toshiba Medical Systems, Otawara, Japan). Prior to the initiation of the diagnostic CT scan, a series of low-radiation sequential axial pre-diagnostic CT images were acquired at a fixed level of the PA bifurcation while the test bolus of contrast media was being injected at 3ml/s with 10ml amount. This pre-diagnostic CT scan was applied for all patients. The scan parameters were as the following: 5 mm section thickness, 100kVp, automatic exposure control of current (mA), and 0.5 second rotation time. Following the completion of the pre-diagnostic CT scan, the patient was given a breath-hold instruction for the standard diagnostic CT using either TB or BT method. Scanning was performed in the cranial-caudal direction.
All cases were administrated contrast medium with 300 mg iodine (I)/ml Omnipaque using a dual-power injector (MEDRAD Stellant CT injector). All cases were administrated 10ml of contrast medium for establishment of pre-diagnostic CT images. The total volume of contrast media was fixed at 70 or 80 ml in accordance with the designed injection protocols. For all cases, a right upper limb antecubital venous access was achieved using an 18 or 20 Gauge venous catheter. The biphasic contrast injection protocol was conducted with two connected phases of contrast medium injection immediately followed by saline flush. The investigators performed the saline flush at the rate of 3ml/s following the administration of the contrast medium with different amounts (20 or 30 ml) to achieve 100ml fluid injection in total.
Estimation of radiation dose The dose length product (DLP) of all cases was recorded. Effective radiation dose was estimated by multiplying the DLP by a conversion factor. The effective radiation dose correlates with different parts of the body which varies the radiation sensitivity of the tissue. Our study applied conversion factor of 0.014 mSV/(mGy x cm) based on the region of chest and abdomen.
Statistical analysis:
A one-way analysis of variance (ANOVA) test was used for comparing the data of 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. All statistical analysis was performed using software (SPSS version 25.0, IBM Corp.).
- Being tested
- Different contrast media injection methods
- Keywords
- computed tomography angiography, aortic dissection, pulmonary embolism, contrast media
- Medical subject headings
- Aortic Dissection, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different contrast media injection methodsDiagnostic test
Different contrast media injection methods
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Different contrast media injection methods |
| 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. Receives: Diagnostic Test: Different contrast media injection methods |
| 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. Receives: Diagnostic Test: Different contrast media injection methods |
| 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. Receives: Diagnostic Test: Different contrast media injection methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancement of the aorta
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.
Measured: Through study completion, an average of 1 year
Enhancement of the pulmonary artery
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Radiation dose
The overall radiation dose for the complete CT angiography will be recorded for each subject in the four experimental groups. Then, statistical analysis will be conducted to evaluate which group shows less radiation exposure.
The statistical analysis is the following:
A one-way analysis of variance (ANOVA) test was used for comparing the average radiation dose 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Mar 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enhancement of Aorta and Pulmonary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chao Huang, MD, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04832633
- Sponsor's protocol ID
- 18MMHIS052e
- Status last verified
- Apr 2021
- First submitted
- 31 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh CC, Zeng AB, Chen CH, Jhou ZY, Wang CH, Yang YL, Hsieh FC, Lin JK, Yeh JY, Huang CC. A practical biphasic contrast media injection protocol strongly enhances the aorta and pulmonary artery simultaneously using a single CT angiography scan. BMC Med Imaging. 2021 Oct 30;21(1):160. doi: 10.1186/s12880-021-00691-4.
PubMed 34717585
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Best Parameters for Imaging Agent Injection and Scanning Methods in Computed Tomography Angiography
- ClinicalTrials.gov ID
- NCT04832633
- Acronym / sponsor ID
- 18MMHIS052e
- Keywords
- computed tomography angiography, aortic dissection, pulmonary embolism, contrast media
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The investigators designed four groups, including two groups using the test bolus (TB) method and two groups using the bolus-tracking (BT) method. The two TB groups were different at the total amount of contrast media with 80ml and 70ml respectively. The P and A seconds were calculated from the pre-diagnostic images and the start time of scan was fixed at A seconds. Based on the results of initial 22 cases in the two TB groups, the mean interval between P and A seconds was approximately 9.5 seconds. Therefore, we roughly assumed the A-P interval in most cases was about 10 seconds and designed the two BT groups with a fixed 10-second first phase contrast media injection time. The start time of scan was based on the tracking method when the descending aorta at the PA bifurcation achieved the baseline density plus 150 HU. The tracking scan started after contrast injection was initiated for 15 seconds. The two BT groups were also different at the total amount of contrast media with 80ml and 70ml respectively, including the 10ml for the pre-diagnostic images in order to have the same condition before the diagnostic CT images.
Details of the four experimental groups:
- TB I: The investigators use the TB method with biphasic injection, followed by the saline flush. Initially, the investigators 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. The investigators 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.
- TB II: This group is similar to the TB I. However, the investigators 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.
- BT I: 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, the investigators 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.
- BT II: This group is similar to the BT I. The first phase of injection is the same as the BT I group. The investigators 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.
CT scan technique and contrast medium administration CT was performed using a 320-MDCT (Canon Aquilion PRIME CT scanner, Toshiba Medical Systems, Otawara, Japan). Prior to the initiation of the diagnostic CT scan, a series of low-radiation sequential axial pre-diagnostic CT images were acquired at a fixed level of the PA bifurcation while the test bolus of contrast media was being injected at 3ml/s with 10ml amount. This pre-diagnostic CT scan was applied for all patients. The scan parameters were as the following: 5 mm section thickness, 100kVp, automatic exposure control of current (mA), and 0.5 second rotation time. Following the completion of the pre-diagnostic CT scan, the patient was given a breath-hold instruction for the standard diagnostic CT using either TB or BT method. Scanning was performed in the cranial-caudal direction.
All cases were administrated contrast medium with 300 mg iodine (I)/ml Omnipaque using a dual-power injector (MEDRAD Stellant CT injector). All cases were administrated 10ml of contrast medium for establishment of pre-diagnostic CT images. The total volume of contrast media was fixed at 70 or 80 ml in accordance with the designed injection protocols. For all cases, a right upper limb antecubital venous access was achieved using an 18 or 20 Gauge venous catheter. The biphasic contrast injection protocol was conducted with two connected phases of contrast medium injection immediately followed by saline flush. The investigators performed the saline flush at the rate of 3ml/s following the administration of the contrast medium with different amounts (20 or 30 ml) to achieve 100ml fluid injection in total.
Estimation of radiation dose The dose length product (DLP) of all cases was recorded. Effective radiation dose was estimated by multiplying the DLP by a conversion factor. The effective radiation dose correlates with different parts of the body which varies the radiation sensitivity of the tissue. Our study applied conversion factor of 0.014 mSV/(mGy x cm) based on the region of chest and abdomen.
Statistical analysis:
A one-way analysis of variance (ANOVA) test was used for comparing the data of 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. All statistical analysis was performed using software (SPSS version 25.0, IBM Corp.).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| test bolus(TB) I | Experimental | Diagnostic Test: Different contrast media injection methodsWe 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. |
| test bolus(TB) II | Experimental | Diagnostic Test: Different contrast media injection methodsThis 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. |
| bolus-tracking(BT) I | Experimental | Diagnostic Test: Different contrast media injection methodsInitially, 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. |
| bolus-tracking(BT) II | Experimental | Diagnostic Test: Different contrast media injection methodsThis 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All cases with suspicion of pulmonary embolism or aortic dissection referred for CT angiography in our hospital
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different contrast media injection methodsDifferent contrast media injection methods | Diagnostic test | bolus-tracking(BT) I, bolus-tracking(BT) II, test bolus(TB) I, test bolus(TB) II |
Primary outcome
Enhancement of the aorta
Time frame: 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
Time frame: 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.
1 secondary outcome
Radiation dose
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Derived from this study: PubMed 34717585Hsieh CC, Zeng AB, Chen CH, Jhou ZY, Wang CH, Yang YL, Hsieh FC, Lin JK, Yeh JY, Huang CC. A practical biphasic contrast media injection protocol strongly enhances the aorta and pulmonary artery simultaneously using a single CT angiography scan. BMC Med Imaging. 2021 Oct 30;21(1):160. doi: 10.1186/s12880-021-00691-4.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chun Chao Huang, MD principal investigator
Mackay Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different contrast media injection methods in people with Enhancement of Aorta and Pulmonary Artery and Radiation Exposure, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enhancement of the aorta (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04832633, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2021.