title: Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul 03080, Korea.
authors.forename: Eun-Ah
authors.initials: EA
authors.lastname: Park
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul 03080, Korea.
authors.forename: Whal
authors.initials: W
authors.lastname: Lee
authors.affiliation: Department of Radiology, Ajou University School of Medicine, Suwon 16499, Korea.
authors.forename: Doo Kyoung
authors.initials: DK
authors.lastname: Kang
authors.affiliation: Department of Radiology, Chungbuk National University Hospital, Cheongju 28644, Korea.
authors.forename: Sung Jin
authors.initials: SJ
authors.lastname: Kim
authors.affiliation: Department of Radiology, Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital, Wonju 26426, Korea.
authors.forename: Young-Ju
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Radiology, Ewha Womans University Mokdong Hospital, Seoul 07985, Korea.
authors.forename: Yookyung
authors.initials: Y
authors.lastname: Kim
authors.affiliation: Department of Radiology, Gachon University Gil Medical Center, Incheon 21565, Korea.
authors.forename: Yon Mi
authors.initials: YM
authors.lastname: Sung
authors.affiliation: Department of Radiology, Hanyang University Seoul Hospital, Seoul 04763, Korea.
authors.forename: Soon-Young
authors.initials: SY
authors.lastname: Song
authors.affiliation: Department of Radiology, Korea University Anam Hospital, Seoul 02841, Korea.
authors.forename: Yu-Whan
authors.initials: YW
authors.lastname: Oh
authors.affiliation: Department of Radiology, Korea University Guro Hospital, Seoul 08308, Korea.
authors.forename: Hwan Seok
authors.initials: HS
authors.lastname: Yong
authors.affiliation: Department of Radiology, Soonchunhyang University Bucheon Hospital, Bucheon 14584, Korea.
authors.forename: Heon
authors.initials: H
authors.lastname: Lee
authors.affiliation: Department of Radiology, Hallym University Sacred Heart Hospital, Anyang 14068, Korea.
authors.forename: Eui-Yong
authors.initials: EY
authors.lastname: Jeon
authors.affiliation: Department of Radiology, Chonbuk National University Medical School and Hospital, Institute of Medical Science, Research Institute of Clinical Medicine and Biomedical Research Institute, Jeonju 54907, Korea.
authors.forename: Gong-Yong
authors.initials: GY
authors.lastname: Jin
authors.affiliation: Department of Radiology, Severance Hospital, Yonsei University Health System, Seoul 03722, Korea.
authors.forename: Byoung Wook
authors.initials: BW
authors.lastname: Choi
authors.affiliation: Department of Radiology, Seoul National University Bundang Hospital, Seongnam 13620, Korea.
authors.forename: Sang-Il
authors.initials: SI
authors.lastname: Choi
mesh_terms: D000328:Adult; D000368:Aged; D001011:Aorta / Q000000981:diagnostic imaging; D000072226:Computed Tomography Angiography / Q000379:methods*; D003287:Contrast Media / Q000009:adverse effects / Q000737:chemistry*; D003331:Coronary Vessels / Q000000981:diagnostic imaging*; D003404:Creatinine / Q000097:blood; D004311:Double-Blind Method; D004562:Electrocardiography; D005260:Female; D005767:Gastrointestinal Diseases / Q000209:etiology; D064368:Healthy Volunteers; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D007472:Iohexol / Q000009:adverse effects / Q000737:chemistry*; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000209:etiology; D012871:Skin Diseases / Q000209:etiology; D055815:Young Adult
chemical_list: D003287:Contrast Media; D007472:Iohexol; D003404:Creatinine
keywords: Contrast materials; Contrast media; Coronary arteries; Drug safety; Image quality enhancement