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Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

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ClinicalTrials.gov Identifier: NCT02171247
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Description
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Brief Summary:
Computed Tomography Angiogram (CTA) scans are performed routinely to look at the vessels in the body as an alternative to directly injecting contrast into the vessels and taking pictures. Different types of intravenous (into the vein, IV) contrast are available to fill the vessels and make them easier to see. The purpose of the study is to determine the best type of contrast for this scan.

Condition or disease Intervention/treatment Phase
Coronary Computed Tomographic Angiography Drug: Isovue 370 Drug: Visipaque 320 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Study Start Date : April 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Isovue 370
Isovue 370 is a contrast agent with increased iodine concentration.
 Drug: Isovue 370
Isovue 370 is a contrast agent with increased iodine concentration.
Active Comparator: Visipaque 320
Standard protocol is Visipaque 320.
 Drug: Visipaque 320
Visipaque 320 is standard protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Contrast to Noise Ratio [ Time Frame: during scan, approximately 3 hours ]
    Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.

  2. Image Quality [ Time Frame: during scan, approximately 3 hours ]
    Depiction of Branch Vessels - coronary branch depiction was performed as consensus decisions of two blinded radiologists. Criteria used was abscence or presence of vessels.

  3. Motion Artifact [ Time Frame: during scan, approximately 3 hours ]
    The outcome will be measured by individual scores. The scores from multiple readers will be averaged.

  4. Attenuation of the Ascending Aorta and Coronary Arteries [ Time Frame: during scan, approximately 3 hours ]
    The investigator will measure the length of visualized coronary artery for the left anterior descending, left circumflex and right coronary arteries as a way of quantifying visualization of distal coronary segments.


Eligibility Criteria
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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:

  • adult patients who are referred for coronary CTA for suspected or known coronary artery disease

Exclusion Criteria:

  • creatinine greater than 2.0
  • allergy to contrast media
  • patients under the age of 18
  • women who are pregnant or breast feeding
  • patients with cardiac arrhythmia will also be excluded
Contacts and Locations
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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): NCT02171247


Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Daniel T Boll, MD Duke University
More Information
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02171247    
Other Study ID Numbers: Pro00004492
First Posted: June 24, 2014    Key Record Dates
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014
Last Verified: July 2014
Keywords provided by Duke University:
coronary computed tomographic angiography
contrast