American heart journal
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American heart journal · Oct 2011
Randomized Controlled TrialEXamination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome.
Comprehensive safety evaluation of new drugs for diabetes mellitus is needed in the area of cardiovascular (CV) outcomes, particularly in populations with high CV risk. Alogliptin, a dipeptidyl peptidase 4 inhibitor, is under development for the treatment of type 2 diabetes mellitus alone or in combination with other antidiabetic therapies. Long-term CV safety of alogliptin is being established in a randomized, placebo-controlled clinical study in patients with acute coronary syndrome (ACS) using an analytical approach that has both an interim and final assessment. ⋯ For both group sequential analyses, the repeated CIs are calculated to insure simultaneous coverage probabilities of 97.5% for the true HR. Study progress: More than 2,000 ACS patients were randomized as of June 2011. EXAMINE will define the CV safety profile of this dipeptidyl peptidase 4 inhibitor in patients at high risk for CV events.
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American heart journal · Oct 2011
Randomized Controlled TrialInterleukin-1β inhibition and the prevention of recurrent cardiovascular events: rationale and design of the Canakinumab Anti-inflammatory Thrombosis Outcomes Study (CANTOS).
Inflammation contributes to all phases of the atherothrombotic process, and patients with elevated inflammatory biomarkers such as high-sensitivity C-reactive protein (hsCRP) have increased vascular risk. Yet, it remains unknown whether direct inhibition of inflammation will reduce cardiovascular event rates. ⋯ If positive, CANTOS would confirm the inflammatory hypothesis of atherothrombosis and provide a novel cytokine-based therapy for the secondary prevention of cardiovascular disease and new-onset diabetes.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyMode of hospital presentation in patients with non-ST-elevation myocardial infarction: implications for strategic management.
Contemporary non-ST-elevation myocardial infarction-acute coronary syndrome guidelines emphasize early-risk stratification and optimizing therapy including an invasive strategy in high-risk patients. To assess the feasibility of initiating this strategy in the prehospital environment, we examined how such patients are transported to hospital, their risk profile, and the proportion potentially eligible for such a strategy. ⋯ Regional strategies using risk-based triage, early medical therapy, and timely triage to percutaneous coronary intervention centers represents an unrealized opportunity to enhance ST-segment elevation myocardial infarction care.
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American heart journal · Sep 2011
Randomized Controlled Trial Multicenter Study Comparative StudyTemporal changes in emergency department triage of patients with acute myocardial infarction and the effect on outcomes.
All patients who present to an emergency department (ED) are triaged. The ED triage score may determine when patients are seen by a physician. Half of patients with acute myocardial infarction (AMI) were given a low priority score in Ontario in 2000/2001. We assessed the appropriateness of ED triage and its association with quality indicators and outcomes in a more recent AMI cohort and compared this with previous findings. ⋯ Emergency department triage of patients with AMI improved substantially over 5 years. For the third of patients with AMI who continue to receive a low priority score, including 25% of patients with STEMI, the associated delays in diagnosis and therapy were greater than previously and were associated with increased hospital LOS and mortality. Given the impact of this initial, cursory assessment, hospital systems should consider monitoring the quality of their ED triage.
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American heart journal · Sep 2011
Multicenter Study Comparative Study Clinical TrialBerlin Heart EXCOR Pediatric ventricular assist device Investigational Device Exemption study: study design and rationale.
Currently, there are no Food and Drug Administration-approved devices available that can provide long-term mechanical circulatory support to smaller children with severe heart failure as a bridge to heart transplant (HT). In recent years, the Berlin Heart EXCOR Pediatric ventricular assist device (VAD) has emerged as a potential treatment option. Systematic data on the safety and efficacy of the EXCOR are limited. ⋯ The Berlin Heart IDE clinical study will be the first bridge-to-HT VAD study designed exclusively for children. It is anticipated that the study will provide important information on the safety and efficacy of the Berlin Heart EXCOR Pediatric in children while providing valuable lessons into the design and conduct of future VAD studies in children.