Trial Outcomes & Findings for Computed Tomography Arteriograms (CTA) Volume Dose Reduction Study (NCT NCT02669784)

Last Updated: 2019-06-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

At 30 days

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Contrast (Omnipaque) Low Dose (40mL) 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Overall Study STARTED	18	16
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low Dose Contrast (40mL) n=18 Participants 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.	Low Dose Contrast (50mL) n=16 Participants 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.	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=18 Participants	0 Participants n=16 Participants	0 Participants n=34 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=18 Participants	6 Participants n=16 Participants	13 Participants n=34 Participants
Age, Categorical >=65 years	11 Participants n=18 Participants	10 Participants n=16 Participants	21 Participants n=34 Participants
Age, Continuous	66 years n=18 Participants	62 years n=16 Participants	66 years n=34 Participants
Sex: Female, Male Female	6 Participants n=18 Participants	5 Participants n=16 Participants	11 Participants n=34 Participants
Sex: Female, Male Male	12 Participants n=18 Participants	11 Participants n=16 Participants	23 Participants n=34 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	18 participants n=18 Participants	16 participants n=16 Participants	34 participants n=34 Participants
Type of Scan Chest Scan	17 Participants n=18 Participants	0 Participants n=16 Participants	17 Participants n=34 Participants
Type of Scan Abdomen Scan	1 Participants n=18 Participants	0 Participants n=16 Participants	1 Participants n=34 Participants
Type of Scan Abdomen and Pelvis Scan	0 Participants n=18 Participants	4 Participants n=16 Participants	4 Participants n=34 Participants
Type of Scan Chest, Abdomen, and Pelvis Scan	0 Participants n=18 Participants	11 Participants n=16 Participants	11 Participants n=34 Participants
Type of Scan Chest and Abdomen Scan	0 Participants n=18 Participants	1 Participants n=16 Participants	1 Participants n=34 Participants
Contrast, 100mL: Scan Dose	18 Participants n=18 Participants	16 Participants n=16 Participants	34 Participants n=34 Participants
Contrast, 100mL: Ascending: Sinotubular Junction Measurement	317.5 hounsfield units n=18 Participants	397.6 hounsfield units n=16 Participants	352.6 hounsfield units n=34 Participants
Contrast, 100mL: Descending: Pulmonary Artery Measurement	283.9 hounsfield units n=18 Participants	338.1 hounsfield units n=16 Participants	329 hounsfield units n=34 Participants
Contrast, 100mL: Celiac Measurement	309.1 hounsfield units n=18 Participants	363.8 hounsfield units n=16 Participants	334.2 hounsfield units n=34 Participants
Contrast, 100mL: Bifurcation Measurement	322.4 hounsfield units n=18 Participants	361.4 hounsfield units n=16 Participants	354.9 hounsfield units n=34 Participants
Contrast, 100mL: Right Common Femoral Measurement	331.3 hounsfield units n=18 Participants	331 hounsfield units n=16 Participants	331 hounsfield units n=34 Participants
Contrast, 100mL: Left Common Femoral Measurement	332 hounsfield units n=18 Participants	350.9 hounsfield units n=16 Participants	348.5 hounsfield units n=34 Participants
Contrast, 100mL: CTA Vessel Opacification Grading 1	4.9 score on a scale n=18 Participants	4.7 score on a scale n=16 Participants	4.79 score on a scale n=34 Participants
Contrast, 100mL: CTA Vessel Opacification Grading 2	4.8 score on a scale n=18 Participants	4.8 score on a scale n=16 Participants	4.8 score on a scale n=34 Participants

PRIMARY outcome

Timeframe: At 30 days

Population: Ascending Sinotubular Junction Measurement was assessed for the following scans: Chest, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=17 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=10 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Ascending Sinotubular Junction Measurement	246.4 Hounsfield units Interval 135.0 to 460.3	287.5 Hounsfield units Interval 125.0 to 443.13

PRIMARY outcome

Timeframe: 30 days

Population: Descending Thoracic Aorta Measurement was assessed for the following scans: Chest, and Chest, Abdomen, \& Pelvis

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.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=17 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=10 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Descending Thoracic Aorta Measurement	261.9 Hounsfield units Interval 119.4 to 452.8	312.8 Hounsfield units Interval 185.3 to 494.3

PRIMARY outcome

Timeframe: 30 days

Population: Celiac Measurement was assessed for all scans: Chest, Abdomen, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=18 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=16 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Celiac Measurement	243.8 Hounsfield units Interval 115.9 to 453.3	329.5 Hounsfield units Interval 146.2 to 813.0

PRIMARY outcome

Timeframe: 30 days

Population: Burfication measurements were taken from the following scans: Abdomen, Abdomen \& Pelvis, and Chest, Abdomen, \& Pelvis.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=1 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=16 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Burfication Measurement	336.2 Hounsfield units Only 1 participant was analyzed therefore a full range cannot be calculated.	321.2 Hounsfield units Interval 126.4 to 581.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=14 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Right Common Femoral Artery Measurement	—	314.5 Hounsfield units Interval 168.9 to 588.5

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=14 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
Left Common Femoral Artery Measurement	—	309.5 Hounsfield units Interval 143.8 to 561.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=18 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=16 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
CTA Vessel Opacification Grading 1	4 score on a scale Interval 2.0 to 5.0	4.3 score on a scale Interval 3.0 to 5.0

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Contrast (Omnipaque) Low Dose (40mL) n=18 Participants 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.	Contrast (Omnipaque) Low Dose (50mL) n=16 Participants CTA of the chest and abdomen 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. This will be compared to the patient's prior examination performed with 100 mL of intravenous contrast.
CTA Vessel Opacification Grading 2	4.2 score on a scale Interval 3.0 to 5.0	4.4 score on a scale Interval 3.0 to 5.0

Adverse Events

Low Dose Contrast (40mL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Low Dose Contrast (50mL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rekha Cherian, M.D.

Milton S. Hershey Medical Center

Phone: 717-531-6735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place