Thoracoabdominal Arortic CTA Study

Phase 4

Completed

• Conditions: Thoracic Aortic Aneurysm
• Interventions: Drug: Isovue

• Registration Number: NCT02291718
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-11
• Study First Posted: 2014-11-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Results First Submitted: 2016-09-28
• Status Verified: 2017-01
• Results First Submitted QC: 2017-01-06
• Results First Posted: 2017-02-24
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients undergoing thoracoabdominal aortic (TAA) CTA
• Able to provide informed consent
• Body Mass Index (BMI) equal to or less than 30

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Exclusion Criteria

• Creatinine greater than 2.0
• Allergy to contrast media
• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isovue 300 75mL	Isovue	Isovue 300 75mL injected 120 kVp 250 mAs
Isovue 370 75mL	Isovue	Isovue 370 75mL injected 100 kVp 240 mAs
Isovue 370 60mL	Isovue	Isovue 370 60mL injected 100 kVp 240 mAs

Primary Outcome Measures

Name	Time	Method
Radiation Dose	30 minutes

Secondary Outcome Measures

Name	Time	Method
Signal to Noise Ratio	30 minutes	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.
Hounsfield Unit Attenuation Values	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.
Variation in Contrast for the Entire Vascular System (coV)	30 minutes	The change in contrast was measured at the proximal segment of the aorta and at the Iliac arteries for each subject.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States