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

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). Ther

SUBMITTER: Park EA 

PROVIDER: S-EPMC4842853 | biostudies-literature | 2016 May-Jun

REPOSITORIES: biostudies-literature