Addition of sodium to the nonionic contrast medium iohexol during coronary angiography in man. Lack of electrocardiographic or hemodynamic effects.

It has recently been claimed that lack of sodium in nonionic contrast media may increase the risk of ventricular arrhythmias during coronary angiography. Thus, the influence of sodium addition to the nonionic contrast medium iohexol was studied in 75 patients with severe coronary heart disease. The study design was randomized, parallel and double-blind, and iohexol was given either with or without addition of NaCl (28 mmol/l). Both formulations induced a transient drop in arterial blood pressure, and prolongation of the QT interval and QRS duration at 10 s only (p less than 0.01). The electrical QRS axis was significantly changed by the coronary artery injections after 10 s, but not later. No differences between iohexol with and without NaCl were observed for any of the variables studied. No serious arrhythmias were observed. Thus, the addition of NaCl (28 mmol/l) to iohexol did not influence the electrocardiographic or hemodynamic changes induced by iohexol during coronary angiography.

A new liposomal liver-specific contrast agent for CT: first human phase-I clinical trial assessing efficacy and safety.

In this first clinical trial liposome-encapsulated iodixanol, CT particles (CTP) were studied. The aims of the present trial were to assess the efficacy of CTP in CT and to determine the safety of different doses of CTP. A total of 47 healthy volunteers were enrolled in the present study. The CTP was administered at doses 10, 30, 70 and 100 mg encapsulated I/kg bw. Efficacy was assessed using single-slice CT of the abdomen and evaluated by dose-response attenuation curves over time in liver, spleen, and abdominal vessels. Safety was assessed by blood tests, clinical examinations and recording of subjective adverse events (AE). The attenuations in liver tissue increased with the dose and maximal values above baseline were 20, 39 and 45 HU at the doses 30, 70 and 100 mg encapsulated I/kg bw, respectively. Maximal increases were seen 12.5 min after contrast administration. As for liver, the attenuations in spleen increased with the dose, but higher attenuations were obtained. In early images clinically significant enhancement was seen in abdominal vessels. Mild and moderate subjective AE were encountered at the doses 70 and 100 mg encapsulated I/kg bw. The CTP is efficacious in enhancing hepatic and splenic tissues and in early imaging of abdominal vessels. Adverse event precludes a clinical use of CTP in the current formulation.

Iodixanol and ioxaglate in cardioangiography: a double-blind randomized phase III study.

A new non-ionic, dimeric contrast medium iodixanol (Nycomed AS, Norway) has a very low osmolality and is isotonic with blood. It has been compared with ioxaglate (Hexabrix, Laboratoire Guerbet, France) in a double-blind, randomized, parallel trial. The aims of the trial were to evaluate and compare the safety (vital signs, adverse events, discomfort and clinical-chemical parameters in blood and urine) and radiographic efficacy (diagnostic information and radiographic density) of iodixanol 320 mg I/ml vs ioxaglate (Hexabrix 320 mg I/ml) in coronary angiography and left ventriculography. Seventy-six patients referred for cardioangiography, two patients were withdrawn, 36 receiving iodixanol and 38 ioxaglate were included in the trial. Six patients (16%) in the iodixanol group and 16 (42%) patients in the ioxaglate group reported adverse events (P = 0.02). One serious adverse event occurred in the iodixanol group where a patient experienced transient cortical blindness and transitory global amnesia, but the patient recovered completely the day after the examination. Twenty-six patients reported injection-associated sensation of warmth in the iodixanol group versus 34 in the ioxaglate group (P = 0.06). Following contrast injection there were no differences between the groups regarding vital signs (ECG, heart rate, left ventricular pressures). Both contrast media were well tolerated by the kidneys, and on average only minor effects on clinical-chemical parameters in blood and urine were observed in the two groups. The radiographic efficacy was good in both groups.

Iodixanol in cardioangiography. A double-blind parallel comparison between iodixanol 320 mg I/ml and ioxaglate 320 mg I/ml.

Iodixanol (Visipaque) 320 mg I/ml, a non-ionic, dimeric, isotonic contrast medium, was compared to ioxaglate (Hexabrix) 320 mg I/ml in cardioangiography. One hundred and two patients with normal renal function were included in the study. The objectives were to evaluate safety, tolerability, radiographic efficacy and effects on renal function. Adverse events, discomfort, vital signs, clinical chemistry parameters, diagnostic information and radiographic density were recorded. Both contrast media had minor effects on the renal function parameters monitored. The patients who received iodixanol experienced fewer adverse events, significantly less discomfort and had a lower increase in heart rate than did the patients in the ioxaglate group. The radiographic efficacy was good in both groups. Iodixanol 320 mg I/ml is safe and effective for use in cardioangiography.

Serial evaluation of perfusion defects in patients with a first acute myocardial infarction referred for primary PTCA using intravenous myocardial contrast echocardiography.

AIMS: To investigate whether myocardial contrast echocardiography using Sonazoid could be used for the serial evaluation of the presence and extent of myocardial perfusion defects in patients with a first acute myocardial infarction treated with primary PTCA, and specifically, (1) to evaluate safety and efficacy of myocardial contrast echocardiography to detect TIMI flow grade 0--2, (2) to evaluate the success of reperfusion and (3) to predict left ventricular recovery after 4 weeks follow-up. METHODS AND RESULTS: Fifty-nine patients underwent serial myocardial contrast echocardiography, immediately before primary PTCA (MCE1), 1 h (MCE2) and 12--24 h after PTCA (MCE3). A perfusion defect was observed in 21 of 24 patients (88%) with anterior acute myocardial infarction. All but one had TIMI flow grade 0--2 prior to PTCA. Nine of 31 patients (29%) with inferior acute myocardial infarction showed a perfusion defect and all had TIMI flow grade 0-2 prior to PTCA. Restoration of TIMI flow grade 3 was achieved in 73% of the patients by primary PTCA. A reduction in size of the initial perfusion defect of at least one segment (16 segment model) or no defect vs persistent defect in patients with anterior acute myocardial infarction was associated with improved global left ventricular function at 4 weeks; mean global wall motion score index 1.29+/-0.21 vs 1.66+/-0.31 (P=0.009). Multiple regression analysis in patients with an anterior acute myocardial infarction revealed that the extent of the perfusion defect at MCE3 was a significant (P=0.0005) independent predictor for left ventricular recovery at 4 weeks follow-up. The only other independent predictor was TIMI flow grade 3 post PTCA (P=0.007). CONCLUSION: Intravenous myocardial contrast echocardiography immediately prior to primary PTCA seems safe and is capable of detecting the presence of a perfusion defect and its subsequent dynamic changes, particularly in patients with a first anterior acute myocardial infarction. A significant reduction in size of the initial perfusion defect using serial myocardial contrast echocardiography predicts functional recovery after 4 weeks and these findings underscore the potential diagnostic value of intravenous myocardial contrast echocardiography.