A5060829829- Health Systems, Economic Evaluations, Quality of Life
- Acute Myocardial Infarction Research
- Coronary Interventions and Diagnostics
- Cardiac Imaging and Diagnostics
- Health and Medical Research Impacts
- Antiplatelet Therapy and Cardiovascular Diseases
- Meta-analysis and systematic reviews
- Atrial Fibrillation Management and Outcomes
- Statistical Methods in Clinical Trials
- Venous Thromboembolism Diagnosis and Management
- Pharmaceutical Economics and Policy
- Cardiac electrophysiology and arrhythmias
- Ethics in Clinical Research
- Healthcare cost, quality, practices
- Pharmaceutical industry and healthcare
- Heart Failure Treatment and Management
- Clinical practice guidelines implementation
- Healthcare Policy and Management
- Cardiac, Anesthesia and Surgical Outcomes
- Pharmaceutical studies and practices
- Biomedical Ethics and Regulation
- Cardiac Valve Diseases and Treatments
- Cardiovascular Function and Risk Factors
- Cardiac pacing and defibrillation studies
- Primary Care and Health Outcomes
Duke University
2013-2025
United States Food and Drug Administration
2008-2025
Food and Drug Administration
2023-2025
Center for Biologics Evaluation and Research
2016-2023
National Institute on Deafness and Other Communication Disorders
2023
National Institutes of Health
2023
Google (United States)
2020-2022
Alphabet (United States)
2017-2022
Clinical Research Institute
2011-2021
Enzo Life Sciences (United States)
2021
The FDA is developing guidance on the use of “real-world evidence” — health care information from atypical sources, including electronic records, billing databases, and product disease registries to assess safety effectiveness drugs devices.
Antithrombotic therapy with heparin plus aspirin reduces the rate of ischemic events in patients unstable coronary artery disease. Low-molecular-weight has a more predictable anticoagulant effect than standard unfractionated heparin, is easier to administer, and does not require monitoring.
Background —Appropriate treatment policies should include an accurate estimate of a patient’s baseline risk. Risk modeling to date has been underutilized in patients with acute coronary syndromes without persistent ST-segment elevation. Methods and Results —We analyzed the relation between characteristics 30-day incidence death composite or myocardial (re)infarction 9461 elevation enrolled PURSUIT trial [Platelet glycoprotein IIb/IIIa Unstable angina: Receptor Suppression Using Integrilin...
The joint cardiovascular practice guidelines of the American College Cardiology (ACC) and Heart Association (AHA) have become important documents for guiding cardiology establishing benchmarks quality care.To describe evolution recommendations in ACC/AHA distribution across classes levels evidence.Data from all issued 1984 to September 2008 were abstracted by personnel ACC Science Quality Division. Fifty-three on 22 topics, including a total 7196 recommendations, abstracted.The number...
Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis.To assess the association between clopidogrel use and long-term clinical outcomes patients receiving (DES) bare-metal (BMS) for treatment coronary artery disease.An observational study examining consecutive at Duke Heart Center, a tertiary care medical center in Durham, NC, January 1, 2000, July 31, 2005, with follow-up contact 6, 12, 24 months...
Studies have reported that women with acute myocardial infarction in-hospital and long-term outcomes are worse than those of men.To assess sex-based differences in presentation outcome, we examined data from the Global Use Strategies to Open Occluded Coronary Arteries Acute Syndromes IIb study, which enrolled 12,142 patients (3662 8480 men) coronary syndromes, including ST-segment elevation, no unstable angina.Overall, were older men, had significantly higher rates diabetes, hypertension,...
The ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of results database, provide an update relevant policies, show how data can be used gain insight into state clinical research.
The clinical utility of genotype-guided (pharmacogenetically based) dosing warfarin has been tested only in small trials or observational studies, with equivocal results.
Background —Ventricular septal defect (VSD) complicating acute myocardial infarction has been studied primarily in small, prethrombolytic-era trials. Our goal was to determine clinical predictors and angiographic outcomes of this complication the thrombolytic era. Methods Results —We compared enrollment characteristics, patterns, (30-day 1-year mortality) patients enrolled Global Utilization Streptokinase TPA for Occluded Coronary Arteries (GUSTO-I) trial with without a confirmed diagnosis...
Directional coronary atherectomy is a new technique of revascularization by which atherosclerotic plaque excised and retrieved from target lesions. With respect to the rate restenosis clinical outcomes, it not known how this procedure compares with balloon angioplasty, relies on dilation vessel wall. We compared after angioplasty that atherectomy.
In recent years, the number of clinical trials conducted in United States has declined, and majority study sites are now outside States, with marked growth research developing countries. The authors discuss implications globalization make recommendations about how to address challenges that have emerged.
Recent studies have underscored questions about the balance of risk and benefit RBC transfusion. A better understanding nature timing molecular functional changes in stored RBCs may provide strategies to improve We analyzed occurring during storage focusing on deformability, RBC-dependent vasoregulatory function, S -nitrosohemoglobin (SNO-Hb), through which hemoglobin (Hb) O 2 desaturation is coupled regional increases blood flow vivo (hypoxic vasodilation). Five hundred ml from each 15...
The Patient-Centered Outcomes Research Institute (PCORI) has launched PCORnet, a major initiative to support an effective, sustainable national research infrastructure that will advance the use of electronic health data in comparative effectiveness (CER) and other types research. In December 2013, PCORI's board governors funded 11 clinical networks (CDRNs) 18 patient-powered (PPRNs) for period months. CDRNs are based on records sources very large populations receiving healthcare within...
Background —Time to treatment with thrombolytic therapy is a critical determinant of mortality in acute myocardial infarction. Little known about the relationship between time direct coronary angioplasty and clinical outcome. The objectives this study were determine both required perform Global Use Strategies Open Occluded Arteries Acute Coronary Syndromes (GUSTO-IIb) trial its Methods Results —Patients randomized (n=565) divided into groups based on enrollment first balloon inflation....
Recent reports highlight gaps between guidelines-based treatment recommendations and evidence from clinical trials that supports those recommendations. Strengthened reporting requirements for studies registered with ClinicalTrials.gov enable a comprehensive evaluation of the national portfolio.To examine fundamental characteristics interventional in database.A data set comprising 96,346 was downloaded on September 27, 2010, entered into relational database to analyze aggregate data....
<h3>Objective.</h3> —To examine the impact of illness on families seriously ill adults and to determine correlates adverse economic impact. <h3>Design.</h3> —Data were collected during Study Understand Prognoses Preferences for Outcomes Risks Treatment (SUPPORT), a prospective cohort study outcomes, preferences, decision making in hospitalized their families. <h3>Setting.</h3> —Five tertiary care hospitals United States. <h3>Participants.</h3> —The 2661 patients nine diagnostic categories...
BACKGROUND Survival after coronary artery bypass graft surgery (CABG) and medical therapy in patients with disease (CAD) has been studied both randomized trials observational treatment comparisons. Over the past decade, use of angioplasty (PTCA) increased dramatically, without guidance from either or prospective The purpose this study was to describe survival experience a large cohort CAD treated medicine, PTCA, CABG. METHODS AND RESULTS designed as nonrandomized comparison setting an...