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Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial

  • Park, Eun-Ah (Department of Radiology, Seoul National University Hospital) ;
  • Lee, Whal (Department of Radiology, Seoul National University Hospital) ;
  • Kang, Doo Kyoung (Department of Radiology, Ajou University School of Medicine) ;
  • Kim, Sung Jin (Department of Radiology, Chungbuk National University Hospital) ;
  • Kim, Young-Ju (Department of Radiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital) ;
  • Kim, Yookyung (Department of Radiology, Ewha Womans University Mokdong Hospital) ;
  • Sung, Yon Mi (Department of Radiology, Gachon University Gil Medical Center) ;
  • Song, Soon-Young (Department of Radiology, Hanyang University Seoul Hospital) ;
  • Oh, Yu-Whan (Department of Radiology, Korea University Anam Hospital) ;
  • Yong, Hwan Seok (Department of Radiology, Korea University Guro Hospital) ;
  • Lee, Heon (Department of Radiology, Soonchunhyang University Bucheon Hospital) ;
  • Jeon, Eui-Yong (Department of Radiology, Hallym University Sacred Heart Hospital) ;
  • Jin, Gong-Yong (Department of Radiology, Chonbuk National University Medical School and Hospital, Institute of Medical Science, Research Institute of Clinical Medicine and Biomedical Research Institute) ;
  • Choi, Byoung Wook (Department of Radiology, Severance Hospital, Yonsei University Health System) ;
  • Choi, Sang-Il (Department of Radiology, Seoul National University Bundang Hospital)
  • Received : 2015.08.17
  • Accepted : 2016.02.13
  • Published : 2016.06.01

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: $375.8{\pm}71.4HU$ with iohexol-380 vs. $356.3{\pm}61.5HU$ 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.

Keywords

Acknowledgement

Supported by : Central Medical Service (CMS)

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