Comparison of Iohexol-380 and Iohexol-350 for Coronary CT Angiography: A Multicenter, Randomized, Double-Blind Phase 3 Trial.
10.3348/kjr.2016.17.3.330
- Author:
Eun Ah PARK
1
;
Whal LEE
;
Doo Kyoung KANG
;
Sung Jin KIM
;
Young Ju KIM
;
Yookyung KIM
;
Yon Mi SUNG
;
Soon Young SONG
;
Yu Whan OH
;
Hwan Seok YONG
;
Heon LEE
;
Eui Yong JEON
;
Gong Yong JIN
;
Byoung Wook CHOI
;
Sang Il CHOI
Author Information
1. Department of Radiology, Seoul National University Hospital, Seoul 03080, Korea. whal.lee@gmail.com
- Publication Type:Multicenter Study ; Randomized Controlled Trial ; Original Article
- Keywords:
Coronary arteries;
Contrast media;
Contrast materials;
Drug safety;
Image quality enhancement
- MeSH:
Angiography*;
Aorta;
Contrast Media;
Coronary Vessels;
Creatinine;
Drug-Related Side Effects and Adverse Reactions;
Image Enhancement;
Iodine;
Phenobarbital;
Volunteers
- From:Korean Journal of Radiology
2016;17(3):330-338
- CountryRepublic of Korea
- Language:English
-
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.
