A double-blind comparative study of the safety and efficacy of iomeprol in renal intra-arterial digital subtraction angiography.

This randomised, double-blind, parallel group study was to compare the safety, tolerance and diagnostic efficacy of iomeprol and iopamidol, both at an iodine concentration of 150 mgI/ml, in 40 patients with arterial hypertension who required renal intra-arterial digital subtraction angiography (IA-DSA) for suspected renovascular stenosis. All patients underwent extensive pre- and post-contrast clinical, instrumental and laboratory controls for safety assessments. The tolerance to the test contrast media was evaluated in terms of discomfort associated with the injection of the test compounds. Image quality was prospectively graded by two independent readers according to a five-point scale as follows: 1, insufficient; 2, sufficient; 3, good; 4, excellent; E, excessive. The quality of vascular opacification in the region of interest was rated as diagnostic in 87.8% of radiographs obtained in the iomeprol group and in 84.5% in the iopamidol group, without significant differences between the two study groups. The results of angiography were always useful for subsequent patient management. The procedure was always well tolerated. There were no clinically significant changes in vital signs, ECG and laboratory parameters during the study in both groups. The results of our study show that iomeprol 150 mgI/ml, and iopamidol 150 mgI/ml are equally effective, well tolerated and safe contrast agents when used for IA-DSA.

RCT Entities:   Population Interventions Outcomes