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

Phase 3

Completed

• Conditions: Coronary Computed Tomographic Angiography
• Interventions: Drug: Isovue 370; Drug: Visipaque 320

• Registration Number: NCT02171247
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Status Verified: 2014-07
• Results First Submitted: 2014-07-28
• Results First Submitted QC: 2014-07-28
• Last Update Submitted: 2014-07-28
• Results First Posted: 2014-08-15
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isovue 370	Isovue 370	Isovue 370 is a contrast agent with increased iodine concentration.
Visipaque 320	Visipaque 320	Standard protocol is Visipaque 320.

Primary Outcome Measures

Name	Time	Method
Contrast to Noise Ratio	during scan, approximately 3 hours	Contrast-to-noise ratios (CNRs) were calculated as follows: CNR = (vascular attenuation - myocardium attenuation) / SD of mean noise attenuation.
Image Quality	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.
Motion Artifact	during scan, approximately 3 hours	The outcome will be measured by individual scores. The scores from multiple readers will be averaged.
Attenuation of the Ascending Aorta and Coronary Arteries	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.