Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial
- 주제(키워드) Coronary arteries , Contrast media , Contrast materials , Drug safety , Image quality enhancement
- 등재 SCIE, SCOPUS, KCI등재
- 발행기관 KOREAN RADIOLOGICAL SOC
- 발행년도 2016
- 총서유형 Journal
- URI http://www.dcollection.net/handler/ewha/000000130372
- 본문언어 영어
- Published As http://dx.doi.org/10.3348/kjr.2016.17.3.330
- 저작권 이화여자대학교 논문은 저작권에 의해 보호받습니다.
초록/요약
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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