The international journal of cardiovascular imaging
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Int J Cardiovasc Imaging · Jun 2013
Randomized Controlled Trial Multicenter StudyA randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.
The purpose of this study was to compare the safety and efficacy of the short-acting β1-receptor blocker, landiolol hydrochloride (0.06 and 0.125-mg/kg), to placebo during coronary computed tomography angiography (CTA) in a phase 2 dose-finding study. A total of 183 patients suspected of having ischemic cardiac disease and scheduled to undergo an invasive coronary angiography were randomized to groups treated with landiolol hydrochloride (0.06 or 0.125-mg/kg) or placebo. The heart rate, safety, and the performance of coronary diagnosis using landiolol hydrochloride were evaluated in a multicenter, double-blind, randomized, parallel study. ⋯ The proportion of correctly classified patients was significantly higher in the 0.125-mg/kg landiolol hydrochloride group than in the placebo group (73.6 vs. 50.0 %). Landiolol hydrochloride at doses of 0.06 and 0.125-mg/kg significantly decreased the heart rate compared with a placebo. The present findings suggest that landiolol hydrochloride is safe and useful at a dose of 0.125-mg/kg to improve coronary diagnostic performance during coronary CTA.
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Int J Cardiovasc Imaging · Jun 2013
Randomized Controlled Trial Multicenter StudyAttenuation of the side effect profile of regadenoson: a randomized double-blind placebo-controlled study with aminophylline in patients undergoing myocardial perfusion imaging and have severe chronic kidney disease--the ASSUAGE-CKD trial.
A subgroup analysis of the ASSUAGE trial suggested that the standardized intravenous aminophylline administration following regadenoson-stress leads to substantial attenuation of regadenoson adverse-effects in patients with severe chronic kidney disease (CKD). In a randomized, double-blinded, placebo-controlled clinical trial of patients with stage 4 and 5 CKD, we compared the frequency and severity of regadenoson adverse-effects in those who received 75 mg of intravenous aminophylline versus a matching placebo administered 90 s post-radioisotope injection. Consecutive 300 patients with severe CKD (36% women; 86% end-stage renal disease; age 55 (±13) years) were randomized to receive aminophylline (n = 150) or placebo (n = 150). ⋯ The stress protocol was better tolerated in the aminophylline group (P = 0.008). The quantitative summed difference score, as a measure of stress-induced ischemic burden, was similar between the study groups (P = 0.51). In conclusion, the routine standardized administration of intravenous aminophylline in patients with severe CKD substantially reduces the frequency and severity of the adverse-effects associated with regadenoson-stress without changing the ischemic burden. [NCT01336140].
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Int J Cardiovasc Imaging · Feb 2012
Randomized Controlled TrialThe absence of coronary artery calcification does not rule out the presence of significant coronary artery disease in Asian patients with acute chest pain.
The absence of coronary artery calcification (CAC) has been used to as an indication to rule out significant coronary artery disease (CAD). However, diagnostic usefulness of 'zero calcium score criteria' as a decision-making strategy to rule out significant CAD as the etiology of acute chest pain has not been studied in depth, especially in Asian ethnicity. We prospectively enrolled 136 Korean patients (58% men, 56 ± 13 years) who presented to the emergency department (ED) with acute chest pain and non-diagnostic ECG. ⋯ Most of the patients with ≥50% CAD of non-calcified plaque were younger than 60 years of age (79%, 11/14), however, 3 of them were older than 60 years of age. Forty-five patients (33%) were subsequently diagnosed as having ACS, and 38% (17/45) of them had no CAC. Zero calcium score did not necessarily guarantee the absence of significant CAD, even in patients older than 60 years, in Asian ethnicity presenting to the ED with chest pain.
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Int J Cardiovasc Imaging · Feb 2008
Randomized Controlled Trial Multicenter StudyAngiographic and 3D intravascular ultrasound assessment of overlapping bare metal stent and three different formulations of drug-eluting stents in patients with diabetes mellitus.
The aim of this study was to examine the impact of overlapping bare-metal stent (BMS) and three different formulations of drug-eluting stent (DES) on intimal hyperplasia (IH) response of patients with diabetes mellitus (DM). ⋯ Overlapping BMS is associated with enhanced IH response in diabetic patients, whereas overlapping DES, particularly SES and PES, appear effective to inhibit IH without detectable late vascular adverse effects.
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Int J Cardiovasc Imaging · Oct 2004
Randomized Controlled Trial Clinical TrialA randomized trial assessing the value of ultrasound-guided puncture of the femoral artery for interventional investigations.
Using a prospectively collected database of patients undergoing diagnostic or therapeutic angiography via transfemoral access, we sought to determine those patients who may benefit from ultrasound-guided puncture of the femoral artery. One-hundred-twelve patients with normal anticoagulation parameters were randomized in two groups. Fifty-six patients received ultrasound-guided puncture of the femoral artery, 56 patients underwent traditional palpation-guided vessel cannulation. ⋯ In contrast, time for vessel cannulation was increased in patients with strong arterial pulse using ultrasound guidance. No significant differences were found with respect to diminished complications neither comparing both patient groups nor comparing risk subgroups. In conclusion ultrasound guidance for femoral artery access is recommended only in patients with a weak or absent arterial pulse and obese patients.