Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography

A multicenter, randomized, double-blind phase 3 trial

Eun Ah Park, 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

Research output: Contribution to journalArticle

3 Citations (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.

Original languageEnglish
Pages (from-to)330-338
Number of pages9
JournalKorean Journal of Radiology
Volume17
Issue number3
DOIs
Publication statusPublished - 2016 May 1

Fingerprint

Iohexol
Coronary Angiography
Drug-Related Side Effects and Adverse Reactions
Aorta
Contrast Media
Computed Tomography Angiography
Coronary Vessels
Iodine
Heart Ventricles
Volunteers
Creatinine
Healthy Volunteers

Keywords

  • Contrast materials
  • Contrast media
  • Coronary arteries
  • Drug safety
  • Image quality enhancement

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging

Cite this

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.

In: Korean Journal of Radiology, Vol. 17, No. 3, 01.05.2016, p. 330-338.

Research output: Contribution to journalArticle

Park, EA, Lee, W, Kang, DK, Kim, SJ, Kim, YJ, Kim, Y, Sung, YM, Song, SY, Oh, YW, Yong, H-S, Lee, H, Jeon, EY, Jin, GY, Choi, BW & Choi, SI 2016, 'Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography: A multicenter, randomized, double-blind phase 3 trial', Korean Journal of Radiology, vol. 17, no. 3, pp. 330-338. https://doi.org/10.3348/kjr.2016.17.3.330
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. / Comparison of Iohexol-380 and Iohexol-350 for coronary CT angiography : A multicenter, randomized, double-blind phase 3 trial. In: Korean Journal of Radiology. 2016 ; Vol. 17, No. 3. pp. 330-338.
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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.",
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T2 - A multicenter, randomized, double-blind phase 3 trial

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AU - Lee, Whal

AU - Kang, Doo Kyoung

AU - Kim, Sung Jin

AU - Kim, Young Ju

AU - Kim, Yookyung

AU - Sung, Yon Mi

AU - Song, Soon Young

AU - Oh, Yu Whan

AU - Yong, Hwan-Seok

AU - Lee, Heon

AU - Jeon, Eui Yong

AU - Jin, Gong Yong

AU - Choi, Byoung Wook

AU - Choi, Sang Il

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N2 - 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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