Korean J Radiol.  2016 Jun;17(3):330-338. 10.3348/kjr.2016.17.3.330.

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

• Park EA
• Lee W
• Kang DK
• Kim SJ
• Kim YJ
• Kim Y
• Sung YM
• Song SY
• Oh YW
• Yong HS
• Lee H
• Jeon EY
• Jin GY
• Choi BW
• Choi SI

• KMID: 2451408
• DOI: http://doi.org/10.3348/kjr.2016.17.3.330

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.

Keyword

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

MeSH Terms

Adult
Aged
Aorta/diagnostic imaging
Computed Tomography Angiography/*methods
Contrast Media/adverse effects/*chemistry
Coronary Vessels/*diagnostic imaging
Creatinine/blood
Double-Blind Method
Electrocardiography
Female
Gastrointestinal Diseases/etiology
Healthy Volunteers
Humans
Image Interpretation, Computer-Assisted
Iohexol/adverse effects/*chemistry
Male
Middle Aged
Nervous System Diseases/etiology
Skin Diseases/etiology
Young Adult
Contrast Media
Creatinine
Iohexol

Figure

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  Fig. 1 Study flow.

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  Fig. 2 Assessment of attenuation in three anatomical regions including ascending aorta (A), left main coronary artery (B), and left ventricular cavity (C). Circles indicate regions of interest placed at each region.

• 

  Fig. 3 Flow diagram of study patients.

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