Novel Tissue Factor Inhibition for Thromboprophylaxis in COVID-19: Primary Results of the ASPEN-COVID-19 Trial.

Background: Thrombo-inflammation is central to COVID-19-associated coagulopathy. TF (tissue factor), a driver of disordered coagulation and inflammation in viral infections, may be a therapeutic target in COVID-19. The safety and efficacy of the novel TF inhibitor rNAPc2 (recombinant nematode anticoagulation protein c2) in COVID-19 are unknown.

Caregiver Faculty: Working through a Pandemic.

Myriad research examines benefits and drawbacks of working from home, both pre- and post-pandemic. Our research looks at how work from home mandates due to the COVID-19 pandemic were implemented, primarily by those who also had caregiver roles to fulfill. We used a convenience sample, drawing from full-time college faculty at a mid-sized state college in Florida, gathering information from caregivers and non-caregivers for comparative purposes.

Dose-limiting, adverse event-associated bradycardia with β-blocker treatment of atrial fibrillation in the GENETIC-AF trial.

Background: Heart failure (HF) patients with atrial fibrillation (AF) often have conduction system disorders, which may be worsened by β-blocker therapy.

Objective: In a post hoc analysis we examined the prevalence of bradycardia and its association with adverse events (AEs) and failure to achieve target dose in the GENETIC-AF trial.

Methods: Patients randomized to metoprolol (n = 125) or bucindolol (n = 131) entering 24-week efficacy follow-up and receiving study medication were evaluated.

Rationale and design of a study to assess the safety and efficacy of rNAPc2 in COVID-19: the Phase 2b ASPEN-COVID-19 trial.

Background: The interaction between thrombosis and inflammation appears central to COVID-19-associated coagulopathy and likely contributes to poor outcomes. Tissue factor is a driver of disordered coagulation and inflammatory signaling in viral infections and is important for viral replication; therefore, tissue factor may be an important therapeutic target in COVID-19.

Study Design: ASPEN-COVID-19 (NCT04655586) is a randomized, prospective open-label blinded endpoint (PROBE), active comparator Phase 2b trial to evaluate the safety and efficacy of recombinant Nematode Anticoagulant Protein c2 (rNAPc2), a potent tissue factor inhibitor, in patients hospitalized with COVID-19 with elevated D-dimer levels.

Bucindolol Decreases Atrial Fibrillation Burden in Patients With Heart Failure and the Arg389Arg Genotype.

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Clinical Validation of a Novel Quality Management System for Blood Gas, Electrolytes, Metabolites, and CO-Oximetry.

Background: Quality management of point-of-care (POC) blood gas testing focuses on verifying instrument accuracy and precision, in addition to performing daily quality control (QC) checks every 8 h and with each patient test (unless internal calibration is verified every 30 min). At the POC, a risk-based approach is suitable to address both systemic and transient sample-specific errors that may negatively impact patient care.

Methods: We evaluated the performance of the GEM® Premier™ 5000 with next generation Intelligent Quality Management 2 (iQM®2) (Instrumentation Laboratory, Bedford, MA), from the analysis of approximately 84,000 patient samples across 4 sites.

Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined HF Population: The GENETIC-AF Trial.

Objectives: The purpose of this study was to compare the effectiveness of bucindolol with that of metoprolol succinate for the maintenance of sinus rhythm in a genetically defined heart failure (HF) population with atrial fibrillation (AF).

Background: Bucindolol is a beta-blocker whose unique pharmacologic properties provide greater benefit in HF patients with reduced ejection fraction (HFrEF) who have the beta-adrenergic receptor (ADRB1) Arg389Arg genotype.

Methods: A total of 267 HFrEF patients with a left ventricular ejection fraction (LVEF) <0.

The effect of a one-year lifestyle intervention program on carotid intima media thickness.

This study assesses the impact of a year long lifestyle intervention program on carotid intima media thickness (CIMT) in 60 subjects, at-risk for or with coronary artery disease. We calculated mean CIMT at baseline (0.731 +/- 0.

Study design and rationale of a comparison of prasugrel and clopidogrel in medically managed patients with unstable angina/non-ST-segment elevation myocardial infarction: the TaRgeted platelet Inhibition to cLarify the Optimal strateGy to medicallY manage Acute Coronary Syndromes (TRILOGY ACS) trial.

Practice guidelines recommend dual antiplatelet therapy with aspirin and clopidogrel for patients with non-ST-segment elevation acute coronary syndromes (NSTE ACS) regardless of in-hospital management strategy. Prasugrel-a thienopyridine adenosine diphosphate receptor antagonist that provides higher and less variable levels of platelet inhibition than clopidogrel-has demonstrated benefit when used to treat ACS patients undergoing percutaneous coronary intervention. However, the optimal approach to antiplatelet therapy for high-risk, medically managed NSTE ACS patients remains uncertain, as these patients have not been the focus of previous clinical trials of these therapies.

Prasugrel compared with high-dose clopidogrel in acute coronary syndrome. The randomised, double-blind ACAPULCO study.

Compared with the approved dose regimen of clopidogrel (300-mg loading dose [LD], 75-mg maintenance dose [MD]), prasugrel has been demonstrated to reduce ischaemic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In ACS, antiplatelet effects of a prasugrel MD regimen have not been previously compared with either a higher clopidogrel MD or after switching from a higher clopidogrel LD. The objective of this study was to evaluate the antiplatelet effect of a prasugrel 10-mg MD versus a clopidogrel 150-mg MD in patients with ACS who had received a clopidogrel 900-mg LD.

Achievement of heart health characteristics through participation in an intensive lifestyle change program (Coronary Artery Disease Reversal Study).

Purpose: Lifestyle habits and cardiovascular disease (CVD) risk factors are closely linked. Unfortunately, few individuals meet the goals for cardiovascular health that are recommended in public health initiatives. The purpose of this study was to determine the effect of an intensive lifestyle intervention program on the achievement of a group of recognized heart health characteristics as well as on the reduction of individual CVD risk factors.

Role of environmental surveillance in determining the risk of hospital-acquired legionellosis: a national surveillance study with clinical correlations.

Objective: Hospital-acquired Legionella pneumonia has a fatality rate of 28%, and the source is the water distribution system. Two prevention strategies have been advocated. One approach to prevention is clinical surveillance for disease without routine environmental monitoring.

The role of exercise in modulating the impact of an ultralow-fat diet on serum lipids and apolipoproteins in patients with or at risk for coronary artery disease.

Background: Ultralow-fat diets are known to reduce high-density lipoprotein cholesterol (HDL-C) levels. In the setting of a multicomponent lifestyle intervention program, relationships between exercise variables and HDL-C levels were examined to determine whether exercise moderates this dietary effect on serum lipids and apolipoproteins.

Methods: We performed a 3-month, prospective, nonrandomized lifestyle intervention study (< or = 10% dietary fat; aerobic exercise [180 min/wk], group support, and yoga [60 min/day]) in 120 subjects with or at risk for coronary artery disease.

Optimal healing environments for chronic cardiovascular disease.

A substantial increase in chronic cardiovascular disease is projected for the next several decades. This is attributable to an aging population and accelerated rates of obesity and diabetes. Despite technological advances that have improved survival for acute events, there is suboptimal translation of research knowledge for prevention and treatment of chronic cardiovascular illness.

Intensive lifestyle modification: impact on cardiovascular disease risk factors in subjects with and without clinical cardiovascular disease.

Intensive lifestyle modification programs are intended to stabilize or promote regression of coronary artery disease; however, clinical response is often nonuniform, complicating appropriate utilization of resources and prediction of outcome. This study assessed physiological and psychological benefits to 72 persons participating in a prospective, nonrandomized, four-component lifestyle change program and compared response between patients with clinical cardiovascular disease (CVD) and patients with elevated risk factors for CVD but without clinical manifestations of disease. Subjects entering the program due to elevated risk factor levels alone demonstrated equal or greater benefit, in terms of improvement in primary CVD risk factors and reduction in measures of coronary disease risk developed in the Framingham Heart Study, than those with clinical CVD.