Contrast Safety in MRI

. It is a Phase III study and has been done at multiple locations using a double blind procedure, where the interpretation was done by two independent readers who had access only to the images obtained. According to the authors this study is the first of its kind as it was performed as a multicenter study at twelve centers in seven different locations in Europe and on three different kinds of imaging equipment from different manufacturers. The concept of single and triple rate of dosage has also been evaluated for the first time. A wide variety of statistical tools and software have been used which have yielded significant results.

105 patients were chosen for the trial and divided into two groups. At the initiation of the trial only 80 were short listed. 43 of them (81%) were chosen for the single-dose group I (0.1mmol/Kg body weight) and 37 (71%) for the triple-dose group II (0.3 mmol/Kg). All these patients had a history of ischemic and coronary heart disease, thrombosis, arterial hypertension, hypercholesterolemia, and/or diabetes mellitus.

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The results of MRA of these two groups administered two different doses of Gadodiamide were compared with those of digital subtraction angiography (DSA). The main effectiveness parameter for comparison of the two dose groups analyzed was the contrast index (CIx), which was calculated from the signal intensities measured in the regions of interest in the abdominal aorta at the aortic bifurcation and 2 cm proximal and 2 cm distal to the main stenosis.

The difference in degree of stenosis was analyzed overall and for three categories. Category I consisted of stenosis of 69% or less. category II, stenosis between 70% and 99%. and category III, occlusions.

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