Trial Outcomes & Findings for Comparison of Contrast Agents During CT Angiography (NCT NCT01534975)

NCT ID: NCT01534975

Last Updated: 2018-03-01

Results Overview

Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 513 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2018-03-01

Participant Flow

Participant milestones

Measure	Iodixanol 320 group 1 Iodixanol 320	Iohexol 350 group 2 iohexol 350	Iopamidol 370 group 3 iopamidol 370	Iodixanol 270 group 4 iodixanol 270
Overall Study STARTED	136	133	160	84
Overall Study COMPLETED	136	133	160	84
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Contrast Agents During CT Angiography

Baseline characteristics by cohort

Measure	Iodixanol 320 n=136 Participants group 1 will receive iodixanol 320 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography	Iohexol 350 n=133 Participants group 2 will receive iohexol 350 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography	Iopamidol 370 n=160 Participants group 3 will receive iopamidol 370 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography	Iodixanol 270 n=84 Participants group 4 will receive iodixanol 270 as the contrast agent during CT acquisition. this will reflect the "intervention" of that arm, by testing the diagnostic ability of this contrast agent to perform cardiac CT angiography	Total n=513 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	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants	90 Participants n=7 Participants	110 Participants n=5 Participants	60 Participants n=4 Participants	352 Participants n=21 Participants
Age, Categorical >=65 years	44 Participants n=5 Participants	43 Participants n=7 Participants	50 Participants n=5 Participants	24 Participants n=4 Participants	161 Participants n=21 Participants
Age, Continuous	62 years STANDARD_DEVIATION 11.7 • n=5 Participants	62.3 years STANDARD_DEVIATION 11.4 • n=7 Participants	61.4 years STANDARD_DEVIATION 10.8 • n=5 Participants	60.4 years STANDARD_DEVIATION 11.2 • n=4 Participants	62 years STANDARD_DEVIATION 11.1 • n=21 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	63 Participants n=7 Participants	76 Participants n=5 Participants	40 Participants n=4 Participants	245 Participants n=21 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	70 Participants n=7 Participants	84 Participants n=5 Participants	44 Participants n=4 Participants	268 Participants n=21 Participants
Region of Enrollment United States	136 participants n=5 Participants	133 participants n=7 Participants	160 participants n=5 Participants	84 participants n=4 Participants	513 participants n=21 Participants

PRIMARY outcome

Timeframe: 1 year

Attenuation (HU) in the ascending aorta, standard deviation (SD) of aorta, will be measured,.

Outcome measures

Measure	Iodixanol 320 n=136 Participants group 1	Iohexol 350 n=133 Participants group 2	Iopamidol 370 n=160 Participants group 3	Iodixanol 270 n=84 Participants group 4
Image Quality of the CT Scans Using Different Contrast Agents	333 hounsfield units Standard Deviation 59	357 hounsfield units Standard Deviation 64	362 hounsfield units Standard Deviation 68	288 hounsfield units Standard Deviation 61

Adverse Events

Iodixanol 320

Serious events: 0 serious events

Other events: 98 other events

Deaths: 0 deaths

Iohexol 350

Serious events: 0 serious events

Other events: 122 other events

Deaths: 0 deaths

Iopamidol 370

Serious events: 0 serious events

Other events: 152 other events

Deaths: 0 deaths

Iodixanol 270

Serious events: 0 serious events

Other events: 52 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Iodixanol 320 n=136 participants at risk group 1 iodixanol 320	Iohexol 350 n=133 participants at risk group 2 iohexol 350	Iopamidol 370 n=160 participants at risk group 3 iopamidol 370	Iodixanol 270 n=84 participants at risk group 4 iodixanol 270
Blood and lymphatic system disorders flushing	72.1% 98/136 • Number of events 98	91.7% 122/133 • Number of events 122	95.0% 152/160 • Number of events 152	61.9% 52/84 • Number of events 52

Additional Information

Matthew Budoff

Los Angeles Biomedical Research Institute

Phone: 3102224107

Email: mbudoff@labiomed.org

Results disclosure agreements

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