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Completed

NCT Number: NCT02171247

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

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.

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Key information

Conditions

Coronary Computed Tomographic Angiography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Isovue 370

Drug

Isovue 370 is a contrast agent with increased iodine concentration.

Visipaque 320

Drug

Visipaque 320 is standard protocol.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Comparison of the Use of High Iodine Concentration Contrast Material (Isovue 370) vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jun 24, 2014
Registry last updated
Aug 15, 2014

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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