Comparison of Contrast Agents During CT Angiography

Completed · Not applicable

Conditions studied: Contrast Enhancement on Cardiac CT

In brief

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.

Key facts

Study ID

NCT01534975

Run by

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

People needed

513

Starts

2012-01-01

Expected to finish

2013-01-01

Last updated by the study team

2018-03-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects may be included in the study if they meet all of the following criteria:
• The subject is over 18 years old.
• Subject scheduled to undergo a contrast-enhanced CCTA examination
• The subject has no contra-indication to receiving iodinated contrast administration (allergy, renal insufficiency).
• The subject has provided signed and dated informed consent

You may not qualify if…

• Subjects must be excluded from participating in this study if they meet the following criteria:
• Subjects have known contra-indication to contrast administration:
• Renal insufficiency as defined by GFR < 50
• Known contrast allergy
• Pregnant or possibly pregnant subjects will be excluded -Women of childbearing potential will undergo urine pregnancy test prior to CT scanning.

Where it is running

• Los Angeles Biomedical Research Institute — Torrance, California, United States

Full record on ClinicalTrials.gov

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