American heart journal
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American heart journal · Feb 2016
ReviewSupporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.
There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. ⋯ Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity.
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American heart journal · Feb 2016
Multicenter StudyCommunity-based automated external defibrillator only resuscitation for out-of-hospital cardiac arrest patients.
Speed is the cornerstone of rescue for out-of-hospital cardiac arrest. As a consequence, community participation programs have been initiated to decrease response times. Even in the very best of these programs, however, short-term survival rates hover around 10% and long-term survival rates are half that. In most locales, survival is far worse. In Piacenza, Italy, responders have been trained for more than a decade to use publicly available automated external defibrillators (AEDs) and eschew the performance of cardiopulmonary resuscitation (CPR). It is known locally as "Progetto Vita." ⋯ This is the first demonstration of excellent long-term survival from out-of-hospital cardiac arrest by promoting speed and ease of lay AED response without CPR.
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American heart journal · Jan 2016
Randomized Controlled Trial Multicenter StudyHigh-degree atrioventricular block, asystole, and electro-mechanical dissociation complicating non-ST-segment elevation myocardial infarction.
Non-ST-segment myocardial infarction (NSTEMI) can be complicated by high-degree atrioventricular (AV) block, asystole, or electromechanical dissociation (EMD), but these events are not well characterized in the contemporary era. This analysis assesses the incidence of and factors associated with these dysrhythmias in acute NSTEMIs. ⋯ Although high-degree AV block, asystole, and EMD were infrequent complications of NSTEMI, they were associated with substantial short-term mortality. Only 1 in 8 pacemakers placed in NSTEMI patients during the acute hospitalization was for high-degree AV block.
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American heart journal · Jan 2016
ReviewThe SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications.
Renal sympathetic activation plays a key role in the pathogenesis of hypertension, as demonstrated by high renal norepinephrine spillover into plasma of patients with essential hypertension. Renal denervation has demonstrated a significant reduction in blood pressure in unblinded studies of hypertensive patients. The SYMPLICITY HTN-3 trial, the first prospective, masked, randomized study of renal denervation versus sham control, failed its primary efficacy end point and raised important questions around potentially confounding factors, such as drug changes and adherence, study population, and procedural methods. ⋯ The studies will randomize patients with combined systolic-diastolic hypertension to renal denervation or sham procedure. Both studies allow renal denervation treatments in renal artery branches and accessories. These studies will inform the design of the second pivotal phase of the program, which will more definitively analyze the antihypertensive effect of renal denervation.
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American heart journal · Dec 2015
Multicenter Study Clinical Trial Observational StudyAntithrombotic strategy variability in ATrial fibrillation and obstructive coronary disease revascularized with PCI-rationale and study design of the prospective observational multicenter AVIATOR 2 registry.
In the era of novel antithrombotic therapy, the optimal treatment for patients with nonvalvular atrial fibrillation (AF) or flutter undergoing percutaneous coronary intervention (PCI) is undetermined. ⋯ AVIATOR 2 is a real-world registry designed to evaluate ischemic and bleeding outcomes according to conventional and novel antithrombotic regimens in patients with nonvalvular AF or flutter undergoing PCI. The study will also provide insights in to physician- and patient-centered factors affecting treatment selection and adherence and their overall impact on clinical outcomes. The study is registered on clinicaltrials.gov NCT02362659.