Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography: A multicenter, randomized, double-blind phase 3 trial

Eun Ah Park, Whal Lee, Doo Kyoung Kang, Sung Jin Kim, Young Ju Kim, Yookyung Kim, Yon Mi Sung, Soon Young Song, Yu Whan Oh, Hwan-Seok Yong, Heon Lee, Eui Yong Jeon, Gong Yong Jin, Byoung Wook Choi, Sang Il Choi

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4 Citations (Scopus)

Abstract

Objective: This multi-center, randomized, double-blind, phase 3 trial was conducted to compare the safety and efficacy of contrast agents iohexol-380 and iohexol-350 for coronary CT angiography in healthy subjects. Materials and Methods: Volunteers were randomized to receive 420 mgI/kg of either iohexol-350 or iohexol-380 using a flow rate of 4 mL/sec. All adverse events were recorded. Two blinded readers independently reviewed the CT images and conflicting results were resolved by a third reader. Luminal attenuations (ascending aorta, left main coronary artery, and left ventricle) in Hounsfield units (HUs) and image quality on a 4-point scale were calculated. Results: A total of 225 subjects were given contrast media (115 with iohexol-380 and 110 with iohexol-350). There was no difference in number of adverse drug reactions between groups: 75 events in 56 (48.7%) of 115 subjects in the iohexol-380 group vs. 74 events in 51 (46.4%) of 110 subjects in the iohexol-350 group (p = 0.690). No severe adverse drug reactions were recorded. Neither group showed an increase in serum creatinine. Significant differences in mean density between the groups was found in the ascending aorta: 375.8 ± 71.4 HU with iohexol-380 vs. 356.3 ± 61.5 HU with iohexol-350 (p = 0.030). No significant differences in image quality scores between both groups were observed for all three anatomic evaluations (all, p > 0.05). Conclusion: Iohexol-380 provides improved enhancement of the ascending aorta and similar attenuation of the coronary arteries without any increase in adverse drug reactions, as compared with iohexol-350 using an identical amount of total iodine.

Original languageEnglish
Pages (from-to)330-338
Number of pages9
JournalKorean Journal of Radiology
Volume17
Issue number3
DOIs
Publication statusPublished - 2016 May 1

Keywords

  • Contrast materials
  • Contrast media
  • Coronary arteries
  • Drug safety
  • Image quality enhancement

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

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    Park, E. A., Lee, W., Kang, D. K., Kim, S. J., Kim, Y. J., Kim, Y., Sung, Y. M., Song, S. Y., Oh, Y. W., Yong, H-S., Lee, H., Jeon, E. Y., Jin, G. Y., Choi, B. W., & Choi, S. I. (2016). Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography: A multicenter, randomized, double-blind phase 3 trial. Korean Journal of Radiology, 17(3), 330-338. https://doi.org/10.3348/kjr.2016.17.3.330