Phase 3
N=33
Comparison of Isovue 370 vs. Standard Protocol in Coronary Computed Tomographic Angiography (CTA)
Coronary Computed Tomographic Angiography
Bottom Line
View on ClinicalTrials.gov: NCT02171247 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Contrast to Noise Ratio — 18.6; 20.5 CNR
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Isovue 370 (Drug); Visipaque 320 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Contrast to Noise Ratio |
18.6; 20.5 | — |
| PRIMARY Image Quality |
43.8; 94.1; 37.5; 82.4; 87.5; 35.3 | — |
| PRIMARY Motion Artifact |
— | — |
| PRIMARY Attenuation of the Ascending Aorta and Coronary Arteries |
19.5; 21.6; 18.4; 20.3 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02171247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.