Trial Outcomes & Findings for Thoracoabdominal Arortic CTA Study (NCT NCT02291718)

NCT ID: NCT02291718

Last Updated: 2017-04-18

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 150 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2017-04-18

Participant Flow

Participant milestones

Measure	Isovue 300 (75mL) 75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan	Isovue 370 (75mL) 75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT	Isovue 370 (60mL) 60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
Overall Study STARTED	50	50	50
Overall Study COMPLETED	50	50	50
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Thoracoabdominal Arortic CTA Study

Baseline characteristics by cohort

Measure	Isovue 300 (75mL) n=50 Participants 75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan	Isovue 370 (75mL) n=50 Participants 75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT	Isovue 370 (60mL) n=50 Participants 60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=5 Participants	15 Participants n=7 Participants	14 Participants n=5 Participants	50 Participants n=4 Participants
Age, Categorical >=65 years	29 Participants n=5 Participants	35 Participants n=7 Participants	36 Participants n=5 Participants	100 Participants n=4 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants	65 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	31 Participants n=7 Participants	23 Participants n=5 Participants	85 Participants n=4 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Measure	Isovue 300 75mL n=50 Participants Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL n=50 Participants Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL n=50 Participants Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Radiation Dose	35.1 mSv Standard Deviation 6.2	25.4 mSv Standard Deviation 5.3	25.5 mSv Standard Deviation 7.0

SECONDARY outcome

Timeframe: 30 minutes

Population: Hiatus region of each subject group

Calculated as the ratio of mean attenuation values divided by the standard deviation of attenuation values gathered using a circular region of interest in the thoracic aorta.

Outcome measures

Measure	Isovue 300 75mL n=50 Participants Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL n=50 Participants Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL n=50 Participants Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Signal to Noise Ratio	12.0 Signal-to-Noise Ratio Standard Deviation 4.8	11.8 Signal-to-Noise Ratio Standard Deviation 3.5	13.8 Signal-to-Noise Ratio Standard Deviation 6.3

SECONDARY outcome

Timeframe: 30 minutes

Grayscale values on CT scans are given as Hounsfield units. These Hounsfield units reflect the attenuation of x-ray beams traversing the aortic lumen. We will use Hounsfield units to assess whether the tool contrast agents achieve similar attenuation characteristics essential for diagnosing aortic abnormalities. We will use circular regions of interest in the thoracic aorta to extract the Hounsfield unit measurements.

Outcome measures

Measure	Isovue 300 75mL n=50 Participants Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL n=50 Participants Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL n=50 Participants Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Hounsfield Unit Attenuation Values	289.7 Hounsfield units Standard Deviation 23.8	400.9 Hounsfield units Standard Deviation 31.1	393.9 Hounsfield units Standard Deviation 28.1

SECONDARY outcome

Timeframe: 30 minutes

The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.

Outcome measures

Measure	Isovue 300 75mL n=50 Participants Isovue 300 75mL injected 120 kVp 250 mAs Isovue: iodine contrast	Isovue 370 75mL n=50 Participants Isovue 370 75mL injected 100 kVp 240 mAs Isovue: iodine contrast	Isovue 370 60mL n=50 Participants Isovue 370 60mL injected 100 kVp 240 mAs Isovue: iodine contrast
Variation in Contrast for the Entire Vascular System (coV)	0.113 unitless Standard Deviation 0.073	0.124 unitless Standard Deviation 0.063	0.107 unitless Standard Deviation 0.059

Adverse Events

Isovue 300 (75mL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Isovue 370 (75mL)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Isovue 370 (60mL)

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

Dr. Lynne Koweek

Duke University Medical Center

Phone: 919-684-8111

Email: lynne.koweek@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place