[Preliminary study and clinical evaluation method of ioversol in angiocardiography--establishment of safety evaluation parameters and reliability of radiographic quality evaluation].

A multi-center clinical study of a new nonionic iodinated contrast medium (ioversol) was performed in 26 patients undergoing left ventriculography (LVG) and coronary angiography (CAG) at four centers. The aims of this study were to try to establish a clinical evaluation method on contrast media in angiocardiography and to determine radiographic efficacy and safety of ioversol. The reliability of the method evaluating the radiographic quality of the contrast medium was also examined with statistical analysis. Excellent radiographic efficacy was observed with ioversol and morphological diagnosis was possible in all cases. The electrocardiograms (ST-segment deflection, T-wave amplitude, QT interval, corrected QT interval, arrhythmia and heart rate) and the hemodynamic parameters (left ventricular systolic and end diastolic pressures, left ventricular dp/dt max, aortic systolic and diastolic pressures) indicated no clinically significant changes. This study suggested that the monitoring of the ECGs and hemodynamic parameters for up to three minutes after injection of the contrast medium is sufficient for the evaluation in LVG and CAG, and that the monitoring in CAG during the first injection into each left and right coronary artery is also sufficient for the purpose. Heat sensation during injection was mild. A patient had a symptom of nausea after ioversol administration, but it was mild and transient and resolved spontaneously. There were no abnormal clinical laboratory data related to ioversol. The reliability of the radiographic quality evaluated by the individual clinical investigators was considered to be high and adaptable. However, the evaluation in the blinded cinefilms by the committee members involving all investigators would be more preferable for the higher objectivity. The study results suggest that ioversol is considered to be the efficacious and safe contrast medium for the cardiovascular angiography.