Comparison of Contrast Agents During CT Angiography (Visipaque)
The purpose of this study is to compare the effects of a certain contrast agent (iodixanol) to two other commonly used contrast agents called Iopamidol (Isovue) and iohexol (Omnipaque), on heart and kidney safety in patients undergoing a cardiac CT angiogram. The investigators will evaluate whether iodixanol 320 (Visipaque®), an iso-osmolar agent, is better tolerated (flushing, injection site pain/warmth, headache, nausea) and provides equal image quality compared with iohexol 350 (Omnipaque®) and Isovue 370 during 64-slice multidetector computed tomography angiography (MDCTA). A fourth group (Visipaque 270) will be included, using low radiation dose technology during acquisition, to evaluate image quality, tolerability, and contrast enhancement compared to both Visipaque 320 and Omnipaque and Isovue. In addition to image quality, tolerability, and contrast enhancement, the investigators will evaluate heart rate, adverse events, reimaging, costs, and patient satisfaction among all four cohorts.
The study will recruit 400 participants already undergoing CT angiography and consent and randomize them to one of four groups. Each of the possible contrast agents used are commonly used for CT angiography, so the primary risk is loss of confidentiality and being asked questions about tolerability. All other facets of the study (3 lead ECG, beta blockade, nitroglycerine use, CT angiography and contrast administration) are standard of care and being done for clinical uses.
Contrast Enhancement on Cardiac CT
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Prospective, Single-Center Double-Blind Randomized Study in Subjects Undergoing Coronary Computed Tomography Angiography (CCTA) Examination (VISIPAQUE Randomized Study)|
- image quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]Attenuation (HU) in the ascending aorta, left ventricular (LV) cavity and LV myocardium (septal and lateral wall) and image noise, standard deviation (SD) of aorta, will be measured, as well as mean change in heart rate over administration time and scan time.
- safety [ Time Frame: 3 days ] [ Designated as safety issue: Yes ]
We will also assess adverse events and complications, including delayed reactions among the four contrast agent groups.
Measurements include: image quality, pt comfort, HR, contrast enhancement, re-image, cost, pt satisfaction, AEs including DARs.
|Study Start Date:||January 2012|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01534975
|United States, California|
|Los Angeles Biomedical Research Institute|
|Torrance, California, United States, 90502|