ABSTRACT
BACKGROUND: Current guidelines on the use of ß-blockers in post-acute myocardial infarction (MI) patients without reduced left ventricular ejection fraction (LVEF) are based on studies before the implementation of modern reperfusion and secondary prevention therapies. It remains unknown whether ß-blockers will reduce mortality and recurrent MI in contemporary revascularized post-MI patients without reduced LVEF. DESIGN: BETAMI is a prospective, randomized, open, blinded end point multicenter study in 10,000 MI patients designed to test the superiority of oral ß-blocker therapy compared to no ß-blocker therapy. Patients with LVEF ≥40% following treatment with percutaneous coronary intervention or thrombolysis and/or no clinical signs of heart failure are eligible to participate. The primary end point is a composite of all-cause mortality or recurrent MI obtained from national registries over a mean follow-up period of 3 years. Safety end points include rates of nonfatal MI, all-cause mortality, ventricular arrhythmias, and hospitalizations for heart failure obtained from hospital medical records 30 days after randomization, and from national registries after 6 and 18 months. Key secondary end points include recurrent MI, heart failure, cardiovascular and all-cause mortality, and clinical outcomes linked to ß-blocker therapy including drug adherence, adverse effects, cardiovascular risk factors, psychosocial factors, and health economy. Statistical analyses will be conducted according to the intention-to-treat principle. A prespecified per-protocol analysis (patients truly on ß-blockers or not) will also be conducted. CONCLUSIONS: The results from the BETAMI trial may have the potential of changing current clinical practice for treatment with ß-blockers following MI in patients without reduced LVEF. EudraCT number 2018-000590-75.
Subject(s)
Adrenergic beta-Antagonists/therapeutic use , Myocardial Infarction/drug therapy , Stroke Volume , Administration, Oral , Adrenergic beta-Antagonists/administration & dosage , Adult , Cause of Death , Humans , Myocardial Infarction/complications , Myocardial Infarction/physiopathology , Myocardial Infarction/prevention & control , Norway , Percutaneous Coronary Intervention , Prospective Studies , Recurrence , Research Design , Secondary Prevention/methods , Thrombolytic Therapy , Ventricular Dysfunction, Left/complications , Ventricular Dysfunction, Left/physiopathology , Ventricular Dysfunction, Left/therapyABSTRACT
The Editors' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
Subject(s)
Authorship/standards , Cardiology/organization & administration , Editorial Policies , Social ResponsibilityABSTRACT
OBJECTIVES: To evaluate long-term and time trends of survival in patients with a clinical diagnosis of type 1 and type 2 diabetes compared to patients without diabetes in a population referred for invasive treatment of coronary disease. METHODS: Patients examined for heart disease at the Feiring LHL Clinics from March 1999 until December 2014 were followed for survival until 20 September, 2015. This yielded 43,872 patients with a known survival status including 1,326 (3.0%) patients with type 1 diabetes and 4,564 (10.9%) with type 2 diabetes. RESULTS: Cox regression revealed a hazard ratio (HR) in type 1 and type 2 diabetes, respectively, of 1.78 (95% confidence interval [CI] 1.60-1.99) and 1.29 (95% CI 1.21-1.37). Comparing survival in the treatment periods before and after 2007, patients without diabetes and with type 2 diabetes had a reduced HR of 0.78 (95% CI 0.72-0.84) and 0.76 (95% CI 0.63-0.91), respectively, but there was no reduction in type 1 diabetes (HR 1.03; 95% CI 0.74-1.42). CONCLUSIONS: Type 1 and type 2 diabetes have excess long-term mortality. In the nondiabetic and type 2 diabetic patients, a reduction in mortality has been noted in recent years, but has not been observed in type 1 diabetic patients.
Subject(s)
Coronary Artery Disease/mortality , Diabetes Mellitus, Type 1/mortality , Diabetes Mellitus, Type 2/mortality , Aged , Coronary Artery Disease/complications , Coronary Artery Disease/therapy , Diabetes Mellitus, Type 1/complications , Diabetes Mellitus, Type 2/complications , Exercise Test , Female , Follow-Up Studies , Humans , Kaplan-Meier Estimate , Male , Middle Aged , Proportional Hazards Models , Stroke VolumeABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship- emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
ABSTRACT
Background: Mediastinitis after coronary bypass grafting (CABG) increases the risk of the internal mammary artery (IMA) graft obstruction, and has a detrimental effect on long-term survival. The pathogenesis for this increased mortality is poorly understood. In the present study, we aimed to investigate the relationship between mediastinitis and persistently elevated cardiac-specific biomarkers [troponin T (TnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP)] and C-reactive protein (CRP) at mid-term follow-up following CABG. Material and methods: The epidemiologic design was of an exposed (mediastinitis, n = 41) vs. randomly selected non-exposed (non-mediastinitis) controls (n = 41) cohort. Serum samples for measurements of NT-proBNP, TnT, and CRP were obtained at a median follow up time of 2.7 (range 0.5-5.2) years after CABG surgery. Results: NT-proBNP (mean 65.0 pg/ml vs. 34.8 pg/ml, p = 0.007) and TnT levels (mean 14.7 ng/L vs. 11.2 ng/L, p = 0.004) were significantly higher in the mediastinitis group than in the control group. Patients with mediastinitis had also higher body mass index (BMI) and were more likely to have diabetes and previous myocardial infarction. There was no difference in serum CRP level between the groups. After controlling for potential confounders (previous myocardial infarction, age, and BMI), the presence of mediastinitis was associated with higher levels of log NT-proBNP (p = 0.02) and log TnT (p = 0.04). Conclusion: Mediastinitis increases the concentrations of cardiac-specific biomarkers NT-proBNP and TnT at mid-term follow-up, representing persistent myocardial injury and impaired cardiac function.
ABSTRACT
OBJECTIVES: Obtain normal reference ranges for left ventricular (LV) volume indexes (VI) and ejection fraction (EF) with fast real-time 3-dimensional echocardiography (RT3DE) with online analysis. DESIGN: After a screening visit 166 healthy participants, 79 males and 87 females aged 29-80 years were examined with RT3DE and Doppler. RESULTS: Upper normal values (mean + 2 standard deviations [SD]) for LV end-diastolic volume index (LVEDVI) and LV end-systolic volume index (LVESVI) were 82 ml/m(2) and 38 ml/m(2), respectively. The lower limit (mean - 2 SD) for LVEF was 49%. LVVI were significantly larger among males (p < 0.001). LV stroke volume (SD) was 87 (22) ml with Doppler vs. 69 (14) ml with RT3DE (p < 0.001). In males there was a positive correlation between age and LVEF (r = 0.34, p = 0.003). In a reproducibility study of RT3DE and 2-dimensional echocardiography (2DE) the coefficients of variability for repeated recordings were 5.7% for LVEDV, 7.7% for LVESV and 6.7% for LVEF with RT3DE, and 8.6%, 8.6% and 6.4% with 2DE, respectively. CONCLUSIONS: These reference values presented from a large group of normal subjects over a wide age range with RT3DE may represent a valuable tool to evaluate if LV systolic dysfunction is present or not.
Subject(s)
Echocardiography, Three-Dimensional , Heart Ventricles/diagnostic imaging , Stroke Volume , Ventricular Function, Left , Adult , Age Factors , Aged , Aged, 80 and over , Body Surface Area , Echocardiography, Doppler , Female , Humans , Image Interpretation, Computer-Assisted , Male , Middle Aged , Norway , Predictive Value of Tests , Reference Values , Reproducibility of Results , Sex FactorsABSTRACT
AIMS: The aim of this study was to obtain normal reference ranges and intra-observer reproducibility for left (L) and right (R) atrial (A) volume indexes (VI, corrected for body surface area) and ejection fractions (EF) with real-time three-dimensional echocardiography. METHODS AND RESULTS: One hundred and sixty-six participants, 79 males and 87 females, aged 29-79 years considered free from clinical and subclinical cardiovascular disease, were included. Normal ranges are defined as 95% reference values for atrial dimensions and reproducibility as coefficients of variations (CVs) for repeated measurements. Upper normal reference values were 41 mL/m(2) for maximum (max) LAVI and 19 mL/m(2) for minimum (min) LAVI. The lower normal reference value was 45% for LAEF. The respective values for RA were 47 mL/m(2), 20 mL/m(2), and 46%. The only relevant gender difference was a higher upper normal max RAVI among males vs. females. The CVs for repeated measurements were 9% for max LAVI, 8% for max RAVI, 13% for LAEF, and 14% for RAEF. CONCLUSION: The present study provides normal ranges for atrial dimensions and contractility with a new, fast, and reproducible technique that can be used bedside without offline analysis.
Subject(s)
Echocardiography, Three-Dimensional/methods , Heart Atria/diagnostic imaging , Stroke Volume/physiology , Adult , Aged , Female , Humans , Male , Middle Aged , Reference Values , Reproducibility of ResultsABSTRACT
BACKGROUND: To obtain normal reference ranges and intraobserver variability for right ventricular (RV) volume indexes (VI) and ejection fraction (EF) from apical recordings with real-time 3-dimensional echocardiography (RT3DE), and similarly for RV area indexes (AI) and area fraction (AF) with 2-dimensional echocardiography (2DE). METHODS: 166 participants; 79 males and 87 females aged between 29-79 years and considered free from clinical and subclinical cardiovascular disease. Normal ranges are defined as 95% reference values and reproducibility as coefficients of variation (CV) for repeated measurements. RESULTS: None of the apical recordings with RT3DE and 2DE included the RV outflow tract. Upper reference values were 62 ml/m2 for RV end-diastolic (ED) VI and 24 ml/m2 for RV end-systolic (ES) VI. Lower normal reference value for RVEF was 41%. The respective reference ranges were 17 cm2/m2 for RVEDAI, 11 cm2/m2 for RVESAI and 27% for RVAF. Males had higher upper normal values for RVEDVI, RVESVI and RVEDAI, and a lower limit than females for RVEF and RVAF. Weak but significant negative correlations between age and RV dimensions were found with RT3DE, but not with 2DE. CVs for repeated measurements ranged between 10% and 14% with RT3DE and from 5% to 14% with 2DE. CONCLUSION: Although the normal ranges for RVVIs and RVAIs presented in this study reflect RV inflow tract dimensions only, the data presented may still be regarded as a useful tool in clinical practice, especially for RVEF and RVAF.
Subject(s)
Echocardiography, Three-Dimensional/methods , Heart Ventricles/diagnostic imaging , Adult , Aged , Female , Humans , Male , Middle Aged , Reference Values , Reproducibility of ResultsABSTRACT
The Editors' Network of the European Society of Cardiology provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
Subject(s)
Authorship , Biomedical Research/methods , Cardiology , Social Responsibility , Societies, Medical , Europe , HumansABSTRACT
The Editors´ Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
Subject(s)
Authorship , Social Responsibility , Cardiology , Editorial Policies , Europe , Humans , TurkeyABSTRACT
The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
ABSTRACT
The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new (fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
Subject(s)
Authorship , Biomedical Research/methods , Cardiology , Editorial Policies , Information Dissemination/methods , HumansABSTRACT
The Editors' Network of the European Society of Cardiology (ESC) provides a dynamic forum for editorial discussions and endorses the recommendations of the International Committee of Medical Journal Editors (ICMJE) to improve the scientific quality of biomedical journals. Authorship confers credit and important academic rewards. Recently, however, the ICMJE emphasized that authorship also requires responsibility and accountability. These issues are now covered by the new -(fourth) criterion for authorship. Authors should agree to be accountable and ensure that questions regarding the accuracy and integrity of the entire work will be appropriately addressed. This review discusses the implications of this paradigm shift on authorship requirements with the aim of increasing awareness on good scientific and editorial practices.
La Red de Editores de la Sociedad Europea de Cardiología (SEC) proporciona un foro dinámico para debates editoriales y respalda las recomendaciones del Comité Internacional de Editores de Revistas Médicas (ICMJE) para mejorar la calidad científica de las revistas biomédicas. La autoría confiere crédito e importantes recompensas académicas. Recientemente, sin embargo, el ICMJE enfatizó que la autoría también requiere responsabilidad y compromiso. Estos problemas ahora están cubiertos por el nuevo (cuarto) criterio de autoría. Los autores deben aceptar ser responsables y garantizar que las preguntas sobre la precisión y la integridad de todo el trabajo será abordado adecuadamente. Esta revisión discute las implicaciones de este cambio de paradigma en requisitos de autoría con el objetivo de aumentar la conciencia sobre las buenas prácticas científicas y editoriales.
Subject(s)
Authorship , Editorial Policies , Publishing/ethics , Social ResponsibilityABSTRACT
BACKGROUND: Invasive coronary angiography is the gold standard for diagnosing coronary artery disease. CT angiography (CTA) is a non-invasive alternative that is more available and less expensive. Previous Norwegian experience with 16-channel CT has been less successful than that reported from other countries. Improved image resolution has increased expectations of a better diagnostic accuracy, but a new local assessment of the method's usefulness is needed before routine usage is implemented. MATERIAL AND METHODS: Patients with suspected stabile coronary disease, referred to invasive coronary angiography, were first assessed with 64-channel CT angiography. Patients with atrial fibrillation or previous bypass operation were not included. All patients who fulfilled the eligibility criteria were included in the study (104), but 13 who had an Agatston calcium score > or = 800 and three for whom the examinations were technically unsuccessful were excluded; the study material therefore consisted of 88 patients. We assessed the method's ability (diagnostic accuracy) to detect diameter stenoses > or = 50% in coronary segments > or = 2 mm (without stent). RESULTS: When 4% non-interpretable segments were interpreted as positive (stenotic), the sensitivity was 97%, the specificity 78% and the positive and negative predictive values were 77 and 98% on a patient level. For 50 patients who did not have significant stenosis, CTA correctly identified 39, but overestimated the degree of stenosis in 11 patients. INTERPRETATION: 64-channel CTA is best at ruling out obstructive coronary artery disease in patients with intermediate risk of such disease. Few patients with significant lesions were missed due to false negative CTA evaluations, but false positive findings are a problem in low risk populations.
Subject(s)
Coronary Angiography/methods , Coronary Disease/diagnostic imaging , Tomography, X-Ray Computed/methods , Aged , False Negative Reactions , False Positive Reactions , Female , Humans , Male , Middle Aged , Sensitivity and SpecificityABSTRACT
BACKGROUND: Recent advances in computed tomography (CT) has made noninvasive imaging of the coronary arteries possible. Multidetector-CT (MDCT)-scanners capable of visualizing the coronary arteries will be available in most Norwegian hospitals within a few years. If the examinations have acceptable quality, diagnostics of coronary pathology could to some extent be decentralized. MATERIAL AND METHODS: Our overview is based on non-systematic review of relevant literature, as well as our own experience. RESULTS AND DISCUSSION: Good results have been shown for 16 and especially for 64 detector scanners in several comparative studies with invasive coronary angiography. The predictive value of a negative test is impressive in all the published studies. Significant coronary pathology is unlikely with a normal MDCT investigation of good quality, but MDCT's imprecise assessment of stenoses generates too many false positive findings. CT-technology is evolving rapidly. Yet, variable image quality and a high radiation dose are still challenging, even with modern CT-scanners. INTERPRETATION: We advocate against uncritical use of the method, however, there is reason for optimism regarding the method's future contribution to coronary diagnostics.
Subject(s)
Coronary Angiography/methods , Tomography, X-Ray Computed/methods , Coronary Angiography/standards , Coronary Disease/diagnostic imaging , Humans , Patient Selection , Predictive Value of Tests , Radiation Dosage , Tomography, X-Ray Computed/standardsSubject(s)
Cardiology , Information Dissemination/methods , Periodicals as Topic , Search Engine , Societies, Medical , Europe , HumansABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability - have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Subject(s)
Clinical Trials as Topic , Editorial Policies , Information Dissemination , Journalism, Medical/standards , Authorship , Bioethics , Cardiology , Disclosure , Societies, MedicalABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors´ Network of the European Society of Cardiology.
Subject(s)
Biomedical Research , Editorial Policies , Information Dissemination , Publishing , Humans , Periodicals as TopicABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship -emphasizing the importance of responsibility and accountability-, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.
Subject(s)
Editorial Policies , Information Dissemination , Guidelines as TopicABSTRACT
The International Committee of Medical Journal Editors (ICMJE) provides recommendations to improve the editorial standards and scientific quality of biomedical journals. These recommendations range from uniform technical requirements to more complex and elusive editorial issues including ethical aspects of the scientific process. Recently, registration of clinical trials, conflicts of interest disclosure, and new criteria for authorship - emphasizing the importance of responsibility and accountability -, have been proposed. Last year, a new editorial initiative to foster sharing of clinical trial data was launched. This review discusses this novel initiative with the aim of increasing awareness among readers, investigators, authors and editors belonging to the Editors' Network of the European Society of Cardiology.