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Completed

NCT Number: NCT02291718

Thoracoabdominal Arortic CTA Study

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.

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Key information

Conditions

Thoracic Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Thoracoabdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isovue

Drug

iodine contrast

Primary outcomes

  1. Radiation Dose

    Time frame: 30 minutes

Secondary outcomes

  1. Signal to Noise Ratio

    Time frame: 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.

  2. Hounsfield Unit Attenuation Values

    Time frame: 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.

  3. Variation in Contrast for the Entire Vascular System (coV)

    Time frame: 30 minutes

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Comparison of High Iodine Concentration Contrast Material (Isovue 370) vs Standard Protocol (Isovue 300) in Thoracoabdominal Aortic Computed Tomographic Angiography (CTA) for Radiation Dose Reduction

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 14, 2014
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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