Aortic and Arterial Anomalies, Aortic Aneurysm, Contrast Induced Nephropathy
Conditions
Brief summary
The purpose of the study is to determine if the dose of contrast (Omnipaque) administered for Computed Tomography Arteriograms (CTA) can be reduced without degradation of image quality. The hypothesis is that there is no difference in image quality using ultra-low dose contrast in CTA exams compared to routine, standard of care dose exams.
Detailed description
Any adult patient age 18 and above, scheduled for routine CTA (Computed Tomography Arteriograms) of the chest or chest, abdomen and pelvis meeting inclusion criteria and not meeting any exclusion criteria will be included in the study. The patient will be administered a low dose of intravenous contrast based on the study examination as described below. CTA of the chest: 40 mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. CTA of the chest and abdomen or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast (Omnipaque) at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. Following the examination, the primary investigator (PI) or team members will evaluate the images obtained with low contrast dose and each patient's prior CTA examination performed with routine contrast dose, 100mL at a rate of 4mL/sec. This will be done by quantitative and qualitative measures. For the quantitative portion, the PI or team members will place regions of interest on predetermined arterial locations to obtain measure the degree of opacification. For qualitative measurement, the images will be presented in a blind fashion to two thoracic trained board certified radiologists and a board certified interventional radiologist to determine the quality of the images based on a Likert numerical scale. Qualitative and quantitative data for the images obtained with low contrast dose and those for the prior CTA examinations performed with routine contrast dose will be compared. This data along with details of the scan protocol (dose, dose rate, scanning parameters etc.) and demographic data (such as sex, age and BMI at the time of examination) will be recorded.
Interventions
DRUGLow Dose Contrast (Omnipaque) 40mL
The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
DRUGLow Dose Contrast (Omnipaque) 50 mL
The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any adult patient scheduled for a computed tomographic arteriogram (CTA) of the chest or chest, abdomen and pelvis who had undergone a prior CTA performed with the standard contrast dose (100 mL) at this institution will be included in the study * The follow-up scan will be routine standard of care, no emergency imaging patient will be approached for this research
Exclusion criteria
* Patients with no prior CTA imaging for comparison * Any pediatric patient (age \<18) * BMI \>40 * Inability to follow instructions * Allergy to intravenous contrast * GFR less than 30 mL/min/1.73 m2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ascending Sinotubular Junction Measurement | At 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction. |
| Descending Thoracic Aorta Measurement | 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. |
| Celiac Measurement | 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis. |
| Burfication Measurement | 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation. |
| Right Common Femoral Artery Measurement | 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. |
| Left Common Femoral Artery Measurement | 30 days | Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery. |
| CTA Vessel Opacification Grading 1 | 30 days | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic study. 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel. |
| CTA Vessel Opacification Grading 2 | 30 days | 5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low Dose Contrast (40mL) CTA of the chest: 40 mL of intravenous contrast at a rate of 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. | 18 |
| Low Dose Contrast (50mL) CTA of the abdomen OR or CTA of the chest and abdomen or CTA of the abdomen and pelvis or CTA of the chest, abdomen and pelvis: 50 mL of intravenous contrast at a rate 5mL/sec. A region of interest (ROI) to trigger the scan will be placed in the aortic arch. If scan is performed using high pitch helical mode, the scan delay will be increased by 2 seconds. The Low Dose scan will then be compared to the standard of care high dose scan of the same area taken at a previous date. | 16 |
| Total | 34 |
Baseline characteristics
| Characteristic | Low Dose Contrast (40mL) | Low Dose Contrast (50mL) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 10 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 6 Participants | 13 Participants |
| Age, Continuous | 66 years | 62 years | 66 years |
| Contrast, 100mL: Ascending: Sinotubular Junction Measurement | 317.5 hounsfield units | 397.6 hounsfield units | 352.6 hounsfield units |
| Contrast, 100mL: Bifurcation Measurement | 322.4 hounsfield units | 361.4 hounsfield units | 354.9 hounsfield units |
| Contrast, 100mL: Celiac Measurement | 309.1 hounsfield units | 363.8 hounsfield units | 334.2 hounsfield units |
| Contrast, 100mL: CTA Vessel Opacification Grading 1 | 4.9 score on a scale | 4.7 score on a scale | 4.79 score on a scale |
| Contrast, 100mL: CTA Vessel Opacification Grading 2 | 4.8 score on a scale | 4.8 score on a scale | 4.8 score on a scale |
| Contrast, 100mL: Descending: Pulmonary Artery Measurement | 283.9 hounsfield units | 338.1 hounsfield units | 329 hounsfield units |
| Contrast, 100mL: Left Common Femoral Measurement | 332 hounsfield units | 350.9 hounsfield units | 348.5 hounsfield units |
| Contrast, 100mL: Right Common Femoral Measurement | 331.3 hounsfield units | 331 hounsfield units | 331 hounsfield units |
| Contrast, 100mL: Scan Dose | 18 Participants | 16 Participants | 34 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 18 participants | 16 participants | 34 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
| Type of Scan Abdomen and Pelvis Scan | 0 Participants | 4 Participants | 4 Participants |
| Type of Scan Abdomen Scan | 1 Participants | 0 Participants | 1 Participants |
| Type of Scan Chest, Abdomen, and Pelvis Scan | 0 Participants | 11 Participants | 11 Participants |
| Type of Scan Chest and Abdomen Scan | 0 Participants | 1 Participants | 1 Participants |
| Type of Scan Chest Scan | 17 Participants | 0 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 16 |
| other Total, other adverse events | 0 / 18 | 0 / 16 |
| serious Total, serious adverse events | 0 / 18 | 0 / 16 |
Outcome results
Primary
Ascending Sinotubular Junction Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. Measurement was taken at the ascending aorta near the sinotubular junction.
Time frame: At 30 days
Population: Ascending Sinotubular Junction Measurement was assessed for the following scans: Chest, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | Ascending Sinotubular Junction Measurement | 246.4 Hounsfield units |
| Contrast (Omnipaque) Low Dose (50mL) | Ascending Sinotubular Junction Measurement | 287.5 Hounsfield units |
Primary
Burfication Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Time frame: 30 days
Population: Burfication measurements were taken from the following scans: Abdomen, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | Burfication Measurement | 336.2 Hounsfield units |
| Contrast (Omnipaque) Low Dose (50mL) | Burfication Measurement | 321.2 Hounsfield units |
Primary
Celiac Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the proximal abdominal aorta at the level of the celiac axis.
Time frame: 30 days
Population: Celiac Measurement was assessed for all scans: Chest, Abdomen, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | Celiac Measurement | 243.8 Hounsfield units |
| Contrast (Omnipaque) Low Dose (50mL) | Celiac Measurement | 329.5 Hounsfield units |
Primary
CTA Vessel Opacification Grading 1
5 Point Grading Scale was used to determine CTA Vessel Opacification by a Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic study. 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | CTA Vessel Opacification Grading 1 | 4 score on a scale |
| Contrast (Omnipaque) Low Dose (50mL) | CTA Vessel Opacification Grading 1 | 4.3 score on a scale |
Primary
CTA Vessel Opacification Grading 2
5 Point Grading Scale was used to determine CTA Vessel Opacification by a second Board Certified Radiologist. 1. Poor opacification with no difference in attenuation of the lumen compared to the wall of the vessel. Non diagnostic. 2. Decreased opacification. Little to no difference in attenuation between the lumen and the wall. Non diagnostic. 3. Moderate opacification of the lumen of the vessel. Diagnostic 4. Good opacification of the lumen of the vessel. 5. Excellent opacification of the lumen of the vessel with distinct difference in attenuation of the wall and lumen of the vessel.
Time frame: 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | CTA Vessel Opacification Grading 2 | 4.2 score on a scale |
| Contrast (Omnipaque) Low Dose (50mL) | CTA Vessel Opacification Grading 2 | 4.4 score on a scale |
Primary
Descending Thoracic Aorta Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the distal abdominal aorta prior to the bifurcation.
Time frame: 30 days
Population: Descending Thoracic Aorta Measurement was assessed for the following scans: Chest, and Chest, Abdomen, \& Pelvis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (40mL) | Descending Thoracic Aorta Measurement | 261.9 Hounsfield units |
| Contrast (Omnipaque) Low Dose (50mL) | Descending Thoracic Aorta Measurement | 312.8 Hounsfield units |
Primary
Left Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Time frame: 30 days
Population: All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the Left common femoral artery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (50mL) | Left Common Femoral Artery Measurement | 309.5 Hounsfield units |
Primary
Right Common Femoral Artery Measurement
Following image acquisition, quantitative analysis was performed by measurement of the attenuation of the contrast bolus by use of Hounsfield Units. A measurement was taken from the right common femoral artery.
Time frame: 30 days
Population: All participants in the Contrast (Omnipaque) Low dose (40mL) underwent only a CTA of the chest or abdomen which is incapable of measuring the right common femoral artery.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Contrast (Omnipaque) Low Dose (50mL) | Right Common Femoral Artery Measurement | 314.5 Hounsfield units |