American heart journal
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American heart journal · May 2014
Randomized Controlled Trial Multicenter StudyRationale and design of the steroids in cardiac surgery trial.
Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CBP). There is a need\ for a large randomized controlled trial to clarify the effect of steroids in such patients. ⋯ SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP.
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American heart journal · Apr 2014
Randomized Controlled TrialVentricular geometric characteristics and functional benefit of mild right ventricular outflow tract obstruction in patients with significant pulmonary regurgitation after repair of tetralogy of Fallot.
Right ventricular (RV) outflow tract obstruction (RVOTO) might protect the RV from adverse remodeling caused by significant pulmonary regurgitation (PR) in patients with repaired tetralogy of Fallot (rTOF), but the underlying mechanisms and influences on exercise tolerance remain unclear. This study sought to investigate the impacts from mild RVOTO on ventricular remodeling and exercise capacity in rTOF. ⋯ Patients with combined PR and mild RVOTO had better RV remodeling and exercise capacity compared to those with isolated PR. Our findings confirm the benefits from mild residual RVOTO support a policy of conservative RVOTO relief at repair.
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American heart journal · Mar 2014
Randomized Controlled Trial Multicenter Study Comparative StudyThe design and rationale for the Acute Medically Ill Venous Thromboembolism Prevention with Extended Duration Betrixaban (APEX) study.
Randomized clinical trials have identified a population of acute medically ill patients who remain at risk for venous thromboembolism (VTE) beyond the standard duration of therapy and hospital discharge. The aim of the APEX study is to determine whether extended administration of oral betrixaban (35-42 days) is superior to a standard short course of prophylaxis with subcutaneous enoxaparin (10 ± 4 days followed by placebo) in patients with known risk factors for post-discharge VTE. Patients initially are randomized to receive either betrixaban or enoxaparin (and matching placebo) in a double dummy design. ⋯ The primary efficacy end point is the composite of asymptomatic proximal deep venous thrombosis, symptomatic deep venous thrombosis, non-fatal (pulmonary embolus) pulmonary embolism, or VTE-related death through day 35. The primary safety outcome is the occurrence of major bleeding. We hypothesize that extended duration betrixaban VTE prophylaxis will be safe and more effective than standard short duration enoxaparin in preventing VTE in acute medically ill patients with known risk factors for post hospital discharge VTE.
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American heart journal · Mar 2014
Randomized Controlled Trial Multicenter Study Comparative StudyDesign and rationale of the TOTAL trial: a randomized trial of routine aspiration ThrOmbecTomy with percutaneous coronary intervention (PCI) versus PCI ALone in patients with ST-elevation myocardial infarction undergoing primary PCI.
A major limitation of primary percutaneous coronary intervention (PPCI) for the treatment of ST-elevation myocardial infarction (STEMI) is impaired microvascular perfusion due to embolization and obstruction of microcirculation with thrombus. Manual thrombectomy has the potential to reduce distal embolization and improve microvascular perfusion. Clinical trials have shown mixed results regarding thrombectomy. ⋯ The TOTAL trial will determine the effect of routine manual aspiration thrombectomy during PPCI on clinically important outcomes.
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American heart journal · Mar 2014
Randomized Controlled Trial Multicenter StudyDETermination of the role of OXygen in suspected Acute Myocardial Infarction trial.
The use of supplemental oxygen in the setting of suspected acute myocardial infarction (AMI) is recommended in international treatment guidelines and established in prehospital and hospital clinical routine throughout the world. However, to date there is no conclusive evidence from adequately designed and powered trials supporting this practice. Existing data are conflicting and fail to clarify the role of supplemental oxygen in AMI. ⋯ The need to clarify the uncertainty of the role of supplemental oxygen therapy in the setting of suspected AMI is urgent. The DETO2X-AMI trial is designed and powered to address this important issue and may have a direct impact on future recommendations.