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Thoracoabdominal Arortic CTA Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291718
Recruitment Status : Completed
First Posted : November 14, 2014
Results First Posted : February 24, 2017
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Thoracic Aortic Aneurysm Drug: Isovue Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Study Start Date : January 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Iopamidol

Arm Intervention/treatment
Active Comparator: Isovue 300 75mL
Isovue 300 75mL injected 120 kVp 250 mAs
Drug: Isovue
iodine contrast

Active Comparator: Isovue 370 75mL
Isovue 370 75mL injected 100 kVp 240 mAs
Drug: Isovue
iodine contrast

Active Comparator: Isovue 370 60mL
Isovue 370 60mL injected 100 kVp 240 mAs
Drug: Isovue
iodine contrast




Primary Outcome Measures :
  1. Radiation Dose [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291718


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02291718    
Other Study ID Numbers: Pro00048275
First Posted: November 14, 2014    Key Record Dates
Results First Posted: February 24, 2017
Last Update Posted: April 18, 2017
Last Verified: January 2017
Keywords provided by Duke University:
Suspected or confirmed
TAA
Computed tomography angiography
CTA
Contrast agent
Radiation dose
Thoracoabdominal aortic aneurysm
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases