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Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial
- Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial
- Park, Eun-Ah; Lee, Whal; Kang, Doo Kyoung; Kim, Sung Jin; Kim, Young-Ju; Kim, Yookyung; Sung, Yon Mi; Song, Soon-Young; Oh, Yu-Whan; Yong, Hwan Seok; Lee, Heon; Jeon, Eui-Yong; Jin, Gong-Yong; Choi, Byoung Wook; Choi, Sang-Il
- Ewha Authors
- SCOPUS Author ID
- Issue Date
- Journal Title
- KOREAN JOURNAL OF RADIOLOGY
- 1229-6929; 2005-8330
- vol. 17, no. 3, pp. 330 - 338
- Coronary arteries; Contrast media; Contrast materials; Drug safety; Image quality enhancement
- KOREAN RADIOLOGICAL SOC
- SCIE; SCOPUS; KCI
- 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.
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