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

Title
Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial
Authors
Park, Eun-AhLee, WhalKang, Doo KyoungKim, Sung JinKim, Young-JuKim, YookyungSung, Yon MiSong, Soon-YoungOh, Yu-WhanYong, Hwan SeokLee, HeonJeon, Eui-YongJin, Gong-YongChoi, Byoung WookChoi, Sang-Il
Ewha Authors
김유경
SCOPUS Author ID
김유경scopus
Issue Date
2016
Journal Title
KOREAN JOURNAL OF RADIOLOGY
ISSN
1229-6929JCR Link2005-8330JCR Link
Citation
vol. 17, no. 3, pp. 330 - 338
Keywords
Coronary arteriesContrast mediaContrast materialsDrug safetyImage quality enhancement
Publisher
KOREAN RADIOLOGICAL SOC
Indexed
SCIE; SCOPUS; KCI WOS 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.
DOI
10.3348/kjr.2016.17.3.330
Appears in Collections:
의과대학 > 의학과 > Journal papers
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