Safety of contrast-enhanced MR angiography employing XXXX 1.0 M as contrast material.

@entity2288 @entity1 @entity8
Our objectives were to evaluate the safety of intravenous 1.0-M @entity2288 injections in @entity1 with an indication for contrast-enhanced magnetic resonance angiography (CE MRA) of supra-aortal, pelvic, or peripheral arteries by examining and assessing adverse events, laboratory values, vital signs and ECG findings for clinical significance. In 435 @entity1 , recruited in three multicenter trials for safety evaluations of the new contrast agent 1.0-M @entity2288 , CE MRA was performed with 1.0- to 1.5-T scanners using three-dimensional gradient-echo sequences and phased-array coils. The study population comprised 312 @entity1 and 123 @entity1 with a mean age of 60.9 years. Two hundred seven @entity1 had an indication for imaging of body arteries and 228 had an indication for imaging of peripheral arteries. Blood laboratory values and urinalysis results of 124 @entity1 as well as heart rate, blood pressure, and 12-lead-electrocardiogram readings of 93 @entity1 obtained during a follow-up period of up to 72 h after the injection of contrast media were available for safety analysis. Contrast media application was performed as intravenous bolus injection of 1.0-M @entity2288 in fixed doses according to the @entity1 ' body weight (b.w.) and indication for CE MRA and was followed by a 20- to 40-ml saline flush. Mean dose actually applied was 0.1 0.27 mmol/kg b.w. Flow rate ranged between 0.2 and 2.0 ml/s. Safety evaluations found a good tolerability with only 4.6% of at least "possibly related" adverse reactions and no clinically relevant changes in blood and urine samples including no transmetallation effect on serum zinc values. Analysis of renal tolerance showed no influence on renal function irrespective of preexisting @entity8 . The ECG analysis (rhythm analysis, pace-setting disturbances, conduction disturbances, and time interval measurements, including uncorrected and corrected QT) showed no clinically relevant effect of the injection of 1.0-M @entity2288 on the cardiac conduction system. Intravenous injection of 1.0-M @entity2288 at a dose of up to 0.1 0.27 mmol/kg b.w. in the indication CE MRA is safe and causes no clinically relevant changes in safety parameters such as heart rate, blood pressure, blood and urine laboratory values, and cardiac conduction system.
