Phase 4
N=150
Thoracoabdominal Arortic CTA Study
Thoracic Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT02291718 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcome: Primary: Radiation Dose — 35.1; 25.4; 25.5 mSv
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Isovue (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Radiation Dose |
35.1; 25.4; 25.5 | — |
| SECONDARY Signal to Noise Ratio |
12.0; 11.8; 13.8 | — |
| SECONDARY Hounsfield Unit Attenuation Values |
289.7; 400.9; 393.9 | — |
| SECONDARY Variation in Contrast for the Entire Vascular System (coV) |
0.113; 0.124; 0.107 | — |
Summary
The purpose of this study is to compare the contrast agents and imaging techniques used for thoracoabdominal aortic imaging in CT. Imaging parameters and contrast volume are changed and adjusted based on the contrast agent, since contrast agents have varying iodine concentrations. If the contrast iodine concentration is higher, it may be possible to adjust the imaging parameters and lower the overall radiation dose to the patient.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing thoracoabdominal aortic (TAA) CTA
- Able to provide informed consent
- Body Mass Index (BMI) equal to or less than 30
Exclusion Criteria
- Creatinine greater than 2.0
- Allergy to contrast media
- Pregnant women
Data sourced from ClinicalTrials.gov (NCT02291718). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.