An open label, prospective, multicenter, non-interventional study of iodixanol 270 mg I/mL for use in individuals undergoing computed tomography angiography in real-world clinical practice

Abstract

Background Concern about radiation exposure is leading to an increasing interest in low-concentration contrast medium administration. Purpose To evaluate the image quality and safety profile after administration of iodixanol 270 mg I/mL at 100-kVp tube voltage with iterative reconstruction in subjects undergoing computed tomography angiography (CTA). Material and Methods Patients who completed CTA examination using iodixanol 270 mg I/mL and 100-kVp tube voltage along with iterative reconstruction for coronary, aortic, head and neck, renal, or pulmonary arteries were included. Image quality was qualitatively and quantitatively evaluated. Incidence of adverse events (AEs) and adverse drug reactions (ADRs) within seven days and radiation dose were also analyzed. Results A total of 4513 individuals in 42 centers in China were enrolled, among which 4367 were included in efficacy analysis. The mean image quality score was 4.8 ± 0.45 across all arteries (all above 4.6) and 99.7% of the individuals’ images were classified as evaluable. The CT attenuation, signal-to-noise ratio (SNR), and contrast-to-noise ratio (CNR) in the regions of interest (ROIs) were 431.79 ± 99.018, 18.29 ± 11.947, and 28.21 ± 19.535 HU, respectively. Of all the participants, 68 (1.5%) and 65 (1.4%) experienced AEs and ADRs, respectively. No serious AEs or AEs leading to discontinuation occurred. The average effective radiation dose was 3.13 ± 2.550 mSv. Conclusion Iodixanol 270 mg I/mL in combination with 100-kVp tube voltage and iterative reconstruction could be safely applied in CTA and yield high-quality and evaluable images with reduced radiation dose.