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

Research output: Contribution to journalArticlepeer-review

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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