RESUMEN
The CARLA study (Cardiovascular Disease, Living and Ageing in Halle) is a longitudinal population-based cohort study of the general population of the city of Halle (Saale), Germany. The primary aim of the cohort was to investigate risk factors for cardiovascular diseases based on comprehensive cardiological phenotyping of study participants and was extended to study factors associated with healthy ageing. In total, 1779 probands (812 women and 967 men, aged 45-83 years) were examined at baseline (2002-2005), with a first and second follow-up performed 4 and 8 years later. The response proportion at baseline was 64.1% and the reparticipation proportion for the first and second follow-up was 86% and 77% respectively. Sixty-four percent of the study participants were in retirement while 25% were full- or partially-employed and 11% were unemployed at the time of the baseline examination. The currently running third follow-up focuses on the assessment of physical and mental health, with an intensive 4 h examination program, including measurement of cardiovascular, neurocognitive, balance and gait parameters. The data collected in the CARLA Study resulted in answering various research questions in over 80 publications, of which two thirds were pooled analyses with other similar population-based studies. Due to the extensiveness of information on risk factors, subclinical conditions and evident diseases, the biobanking concept for the biosamples, the cohort representativeness of an elderly population, and the high level of quality assurance, the CARLA cohort offers a unique platform for further research on important indicators for healthy ageing.
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Enfermedades Cardiovasculares , Anciano , Bancos de Muestras Biológicas , Enfermedades Cardiovasculares/epidemiología , Estudios de Cohortes , Femenino , Factores de Riesgo de Enfermedad Cardiaca , Humanos , Masculino , Factores de RiesgoRESUMEN
The German National Cohort (NAKO) is a multidisciplinary, population-based prospective cohort study that aims to investigate the causes of widespread diseases, identify risk factors and improve early detection and prevention of disease. Specifically, NAKO is designed to identify novel and better characterize established risk and protection factors for the development of cardiovascular diseases, cancer, diabetes, neurodegenerative and psychiatric diseases, musculoskeletal diseases, respiratory and infectious diseases in a random sample of the general population. Between 2014 and 2019, a total of 205,415 men and women aged 19-74 years were recruited and examined in 18 study centres in Germany. The baseline assessment included a face-to-face interview, self-administered questionnaires and a wide range of biomedical examinations. Biomaterials were collected from all participants including serum, EDTA plasma, buffy coats, RNA and erythrocytes, urine, saliva, nasal swabs and stool. In 56,971 participants, an intensified examination programme was implemented. Whole-body 3T magnetic resonance imaging was performed in 30,861 participants on dedicated scanners. NAKO collects follow-up information on incident diseases through a combination of active follow-up using self-report via written questionnaires at 2-3 year intervals and passive follow-up via record linkages. All study participants are invited for re-examinations at the study centres in 4-5 year intervals. Thereby, longitudinal information on changes in risk factor profiles and in vascular, cardiac, metabolic, neurocognitive, pulmonary and sensory function is collected. NAKO is a major resource for population-based epidemiology to identify new and tailored strategies for early detection, prediction, prevention and treatment of major diseases for the next 30 years.
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Estudios Prospectivos , Masculino , Humanos , Femenino , Estudios de Cohortes , Alemania/epidemiología , Encuestas y Cuestionarios , AutoinformeRESUMEN
Physical fitness is defined as an individual's ability to be physically active. The main components are cardiorespiratory fitness (CRF), muscle strength, and flexibility. Regardless of physical activity level, physical fitness is an important determinant of morbidity and mortality.The aim of the current study was to describe the physical fitness assessment methodology in the German National Cohort (NAKO) and to present initial descriptive results in a subsample of the cohort.In the NAKO, hand grip strength (GS) and CRF as physical fitness components were assessed at baseline using a hand dynamometer and a submaximal bicycle ergometer test, respectively. Maximum oxygen uptake (VO2max) was estimated as a result of the bicycle ergometer test. The results of a total of 99,068 GS measurements and 3094 CRF measurements are based on a data set at halftime of the NAKO baseline survey (age 20-73 years, 47% men).Males showed higher values of physical fitness compared to women (males: GSâ¯= 47.8â¯kg, VO2maxâ¯= 36.4â¯ml·min-1⯷ kg-1; females: GSâ¯= 29.9â¯kg, VO2maxâ¯= 32.3â¯ml⯷ min-1⯷ kg-1). GS declined from the age of 50 onwards, whereas VO2max levels decreased continuously between the age groups of 20-29 and ≥60 years. GS and VO2max showed a linear positive association after adjustment for body weight (males ßâ¯= 0.21; females ßâ¯= 0.35).These results indicate that the physical fitness measured in the NAKO are comparable to other population-based studies. Future analyses in this study will focus on examining the independent relations of GS and CRF with risk of morbidity and mortality.
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Prueba de Esfuerzo , Aptitud Física , Adulto , Femenino , Alemania , Fuerza de la Mano , Humanos , Masculino , Oxígeno , Consumo de Oxígeno , Adulto JovenRESUMEN
AIMS: To determine the interaction between HRV and inflammation and their association with cardiovascular/all-cause mortality in the general population. METHODS AND RESULTS: Subjects of the CARLA study (n = 1671; 778 women, 893 men, 45-83 years of age) were observed for an average follow-up period of 8.8 years (226 deaths, 70 cardiovascular deaths). Heart rate variability parameters were calculated from 5-min segments of 20-min resting electrocardiograms. High-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), and soluble tumour necrosis factor-alpha receptor type 1 (sTNF-R1) were measured as inflammation parameters. The HRV parameters determined included the standard deviation of normal-to-normal intervals (SDNN), the root-mean-square of successive normal-interval differences (RMSSD), the low- and high-frequency (HF) power, the ratio of both, and non-linear parameters [Poincaré plot (SD1, SD2, SD1/SD2), short-term detrended fluctuation analysis]. We estimated hazard ratios by using covariate-adjusted Cox regression for cardiovascular and all-cause mortality incorporating an interaction term of HRV/inflammation parameters. Relative excess risk due to interactions (RERIs) were computed. We found an interaction effect of sTNF-R1 with SDNN (RERI: 0.5; 99% confidence interval (CI): 0.1-1.0), and a weaker effect with RMSSD (RERI: 0.4; 99% CI: 0.0-0.9) and HF (RERI: 0.4; 99% CI: 0.0-0.9) with respect to cardiovascular mortality on an additive scale after covariate adjustment. Neither IL-6 nor hsCRP showed a significant interaction with the HRV parameters. CONCLUSION: A change in TNF-α levels or the autonomic nervous system influences the mortality risk through both entities simultaneously. Thus, TNF-α and HRV need to be considered when predicating mortality.
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Sistema Nervioso Autónomo/fisiopatología , Enfermedades Cardiovasculares/fisiopatología , Frecuencia Cardíaca , Corazón/inervación , Inflamación/fisiopatología , Anciano , Anciano de 80 o más Años , Proteína C-Reactiva/análisis , Enfermedades Cardiovasculares/sangre , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/mortalidad , Causas de Muerte , Electrocardiografía , Femenino , Alemania , Humanos , Inflamación/sangre , Inflamación/diagnóstico , Inflamación/mortalidad , Mediadores de Inflamación/sangre , Interleucina-6/sangre , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Estudios Prospectivos , Receptores Tipo I de Factores de Necrosis Tumoral/sangre , Factores de Riesgo , Factores de Tiempo , Factor de Necrosis Tumoral alfa/sangreRESUMEN
AIMS: To assess the value of cardiac structure/function in predicting heart rate variability (HRV) and the possibly predictive value of HRV on cardiac parameters. METHODS AND RESULTS: Baseline and 4-year follow-up data from the population-based CARLA cohort were used (790 men, 646 women, aged 45-83 years at baseline and 50-87 years at follow-up). Echocardiographic and HRV recordings were performed at baseline and at follow-up. Linear regression models with a quadratic term were used. Crude and covariate adjusted estimates were calculated. Missing values were imputed by means of multiple imputation. Heart rate variability measures taken into account consisted of linear time and frequency domain [standard deviation of normal-to-normal intervals (SDNN), high-frequency power (HF), low-frequency power (LF), LF/HF ratio] and non-linear measures [detrended fluctuation analysis (DFA1), SD1, SD2, SD1/SD2 ratio]. Echocardiographic parameters considered were ventricular mass index, diastolic interventricular septum thickness, left ventricular diastolic dimension, left atrial dimension systolic (LADS), and ejection fraction (Teichholz). A negative quadratic relation between baseline LADS and change in SDNN and HF was observed. The maximum HF and SDNN change (an increase of roughly 0.02%) was predicted at LADS of 3.72 and 3.57 cm, respectively, while the majority of subjects experienced a decrease in HRV. There was no association between further echocardiographic parameters and change in HRV, and there was no evidence of a predictive value of HRV in the prediction of changes in cardiac structure. CONCLUSION: In the general population, LADS predicts 4-year alteration in SDNN and HF non-linearly. Because of the novelty of the result, analyses should be replicated in other populations.
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Ecocardiografía Doppler , Cardiopatías/diagnóstico por imagen , Frecuencia Cardíaca , Corazón/diagnóstico por imagen , Corazón/fisiopatología , Periodicidad , Anciano , Anciano de 80 o más Años , Remodelación Atrial , Electrocardiografía , Femenino , Estudios de Seguimiento , Alemania/epidemiología , Cardiopatías/epidemiología , Cardiopatías/fisiopatología , Humanos , Modelos Lineales , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Dinámicas no Lineales , Valor Predictivo de las Pruebas , Estudios Prospectivos , Factores de Tiempo , Función Ventricular Izquierda , Remodelación VentricularRESUMEN
BACKGROUND: Precise blood pressure (BP) measurements are central for the diagnosis of hypertension in clinical and epidemiological studies. The purpose of this study was to quantify the variability in BP associated with arm side, body position, and successive measurements in the setting of a population-based observational study. Additionally, we aimed to evaluate the influence of different measurement conditions on prevalence of hypertension. METHODS: The sample included 967 men and 812 women aged 45 to 83 years at baseline. BP was measured according to a standardized protocol with oscillometric devices including three sitting measurements at left arm, one simultaneous supine measurement at both arms, and four supine measurements at the arm with the higher BP. Hypertension was defined as systolic BP (SBP) ≥140âmmHg and/or diastolic BP (DBP) ≥90âmmHg. Variability in SBP and DBP were analysed with sex-stratified linear covariance pattern models. RESULTS: We found that overall, no mean BP differences were measured according to arm-side, but substantial higher DBP and for men also higher SBP was observed in sitting than in supine position and there was a clear BP decline by consecutive measurement. Accordingly, the prevalence of hypertension depends strongly on the number and scheme of BP measurements taken to calculate the index values. CONCLUSIONS: Thus, BP measurements should only be compared between studies applying equal measurement conditions and index calculation. Moreover, the first BP measurement should not be used to define hypertension since it overestimates BP. The mean of second and third measurement offers the advantage of better reproducibility over single measurements.
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Determinación de la Presión Sanguínea/métodos , Presión Sanguínea , Hipertensión/diagnóstico , Posicionamiento del Paciente , Posición Supina , Extremidad Superior/irrigación sanguínea , Anciano , Anciano de 80 o más Años , Femenino , Alemania/epidemiología , Humanos , Hipertensión/epidemiología , Hipertensión/fisiopatología , Modelos Lineales , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Prevalencia , Reproducibilidad de los Resultados , Factores Sexuales , Factores de TiempoRESUMEN
Although inpatient lifestyle treatment for obese children and adolescents can be highly effective in the short term, long-term results are unconvincing. One possible explanation might be that the treatment takes place far from parents' homes, limiting the possibility to incorporate the parents, who play a major role in establishing and maintaining a healthy lifestyle in childhood and adolescence. The main goal was to develop a brief behaviorally oriented parent training program that enhances 'obesity-specific' parenting skills in order to prevent relapse. We hypothesized that the inclusion of additional parent training would lead to an improved long-term weight course of obese children. Parents of obese children (n = 686; 7-13 years old) either participated in complementary cognitive-behavioral group sessions (n = 336) or received written information only (n = 350) during the inpatient stay. Children of both groups attended multidisciplinary inpatient rehabilitation. BMI-SDS as a primary outcome was evaluated at baseline, post-intervention and at 6- and 12-month follow-up. Intention-to-treat (ITT) as well as per-protocol analyses (PPA) were performed. A significant within-group decrease of 0.24 (95% CI 0.18 to 0.30) BMI-SDS points from the beginning of the inpatient stay through the first year was found, but no group difference at the one-year follow-up (mean difference 0.02; 95% CI -0.04 to 0.07). We also observed an increase in quality of life scores, intake of healthy food and exercise for both groups, without differences between groups (ITT and PPA). Thus, while the inpatient treatment proved highly effective, additional parent training did not lead to better results in long-term weight maintenance or to better psychosocial well-being compared to written psycho-educational material. Further research should focus on subgroups to answer the question of differential treatment effects.
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Terapia Cognitivo-Conductual/educación , Estilo de Vida Saludable , Responsabilidad Parental , Padres/educación , Obesidad Infantil/terapia , Poder Psicológico , Calidad de Vida , Adolescente , Índice de Masa Corporal , Mantenimiento del Peso Corporal , Niño , Terapia Combinada/psicología , Femenino , Estudios de Seguimiento , Alemania , Humanos , Análisis de Intención de Tratar , Masculino , Responsabilidad Parental/psicología , Padres/psicología , Cooperación del Paciente , Pacientes Desistentes del Tratamiento , Educación del Paciente como Asunto , Obesidad Infantil/psicología , Grupo ParitarioRESUMEN
BACKGROUND: Arterial hypertension is a common disease with high prevalence in the general population. Left ventricular hypertrophy (LVH) is an independent risk factor in arterial hypertension. Electrocardiographic indices like the Sokolow-Lyon index (SLI) are recommended as diagnostic screening methods for LVH. We assessed the diagnostic performance of the SLI in a cohort of a large general population. METHODS: We used electrocardiographic and echocardiographic data from the prospective, population-based cohort study CARdio-vascular Disease, Living and Ageing in Halle (CARLA). Linear and logistic regression models were used to assess the association of SLI with LVH. To assess the impact of the body-mass-index (BMI), we performed interaction analyses. RESULTS: AUC of SLI to predict LVH was 55.3 %, sensitivity of the SLI was 5 %, specificity 97 %. We found a significant association of SLI after covariate-adjustment with echocardiographically detected LVH (increase of left-ventricular mass index, LVMI 7.0 g/m(2) per 1 mV increase of SLI, p < 0.0001). However, this association was mainly caused by an association of SLI with the left-ventricular internal diameter (LVIDd, increase of 0.06 cm/m(2) per 1 mV increase of SLI, p < 0.0001). In obese (BMI > 30 kg/m(2)) we found the strongest association with an increase of 9.2 g/m(2) per 1 mV. CONCLUSIONS: Although statistically significant, relations of SLI and echocardiographic parameters of LVH were weak and mainly driven by the increase in LVIDd, implicating a more eccentric type of LVH in the collective. The relations were strongest when obese subjects were taken into account. Our data do not favour the SLI as a diagnostic screening test to identify patients at risk for LVH, especially in non-obese subjects without eccentric LVH.
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Envejecimiento/patología , Ecocardiografía/normas , Hipertrofia Ventricular Izquierda/diagnóstico por imagen , Hipertrofia Ventricular Izquierda/epidemiología , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Femenino , Alemania Oriental/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Estudios ProspectivosRESUMEN
BACKGROUND: Intra-aortic balloon pump counterpulsation (IABP) is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction. Although there has been only limited evidence from randomised controlled trials, the previous guidelines of the American Heart Association/American College of Cardiology (AHA/ACC) and the European Society of Cardiology (ESC) strongly recommended the use of the IABP in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations, non-randomised trials and registry data. The recent guidelines downgraded the recommendation based on a meta-analysis which could only include non-randomised trials showing conflicting results. Up to now, there have been no guideline recommendations and no actual meta-analysis including the results of the large randomised multicentre IABP-SHOCK II Trial which showed no survival benefit with IABP support. This systematic review is an update of the review published in 2011. OBJECTIVES: To evaluate, in terms of efficacy and safety, the effect of IABP versus non-IABP or other assist devices guideline compliant standard therapy on mortality and morbidity in patients with acute myocardial infarction complicated by cardiogenic shock. SEARCH METHODS: Searches of CENTRAL, MEDLINE (Ovid) and EMBASE (Ovid), LILACS, IndMed and KoreaMed, registers of ongoing trials and proceedings of conferences were updated in October 2013. Reference lists were scanned and experts in the field contacted to obtain further information. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials on patients with acute myocardial infarction complicated by cardiogenic shock. DATA COLLECTION AND ANALYSIS: Data collection and analysis were performed according to the published protocol. Individual patient data were provided for six trials and merged with aggregate data. Summary statistics for the primary endpoints were hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CIs). MAIN RESULTS: Seven eligible studies were identified from a total of 2314 references. One new study with 600 patients was added to the original review. Four trials compared IABP to standard treatment and three to other percutaneous left assist devices (LVAD). Data from a total of 790 patients with acute myocardial infarction and cardiogenic shock were included in the updated meta-analysis: 406 patients were treated with IABP and 384 patients served as controls; 339 patients were treated without assisting devices and 45 patients with other LVAD. The HR for all-cause 30-day mortality of 0.95 (95% CI 0.76 to 1.19) provided no evidence for a survival benefit. Different non-fatal cardiovascular events were reported in five trials. During hospitalisation, 11 and 4 out of 364 patients from the intervention groups suffered from reinfarction or stroke, respectively. Altogether 5 out of 363 patients from the control group suffered from reinfarction or stroke. Reocclusion was treated with subsequent re-revascularization in 6 out of 352 patients from the intervention group and 13 out of 353 patients of the control group. The high incidence of complications such as moderate and severe bleeding or infection in the control groups has to be attributed to interventions with other LVAD. Possible reasons for bias were more frequent in small studies with high cross-over rates, early stopping and the inclusion of patients with IABP at randomisation. AUTHORS' CONCLUSIONS: Available evidence suggests that IABP may have a beneficial effect on some haemodynamic parameters. However, this did not result in survival benefits so there is no convincing randomised data to support the use of IABP in infarct-related cardiogenic shock.
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Contrapulsador Intraaórtico/métodos , Infarto del Miocardio/complicaciones , Choque Cardiogénico/terapia , Circulación Asistida/instrumentación , Circulación Asistida/métodos , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Choque Cardiogénico/etiologíaRESUMEN
BACKGROUND: Health literacy (HL) has gained increasing attention in public health research. However, until now research was mainly focused on clinical settings rather than on the general population. Due its relation to social determinants and health outcomes, HL is of special interest in epidemiological studies. The aim of the present study was therefore to describe HL among an elderly general high-risk population, to analyze the potential contributing factors of HL, and to analyze the impact of HL on health-related outcomes. METHODS: We used data from the CARLA Study, which is a prospective population-based cohort study of the elderly general population of the city of Halle (Saale) in Eastern Germany. The short version of the HLS-EU Questionnaire (HLS-EU-Q16) was administered with 1,107 subjects aged between 55 and 91 year old. A HL score ranging from 0 to 50 points was computed and classified according to the recommendation of the HLS-EU project. Socio-economic as well as health-related variables were determined during the standardized interview and clinical examination. We calculated linear as well as logistic regression models in order to analyze the association between HL and health-related outcomes as well as potential influencing factors of HL. RESULTS: Overall, the HL score was 36.9 (SD 6.9). Among all subjects, 4 % showed inadequate HL, 23 % problematic HL, 50 % sufficient HL, and 23 % excellent HL. HL was positively associated with educational level, net household income, and self-perceived social position. Further, we found an increase of HL with age (ß = 0.10; 95 % CL 0.05; 0.15) and a lower HL score among women compared with men (Diff = -1.4; 95 % CL -2.2; -0.6). An inverse association was observed between HL and diabetes among both sexes (OR 0.93; 95 % CL 0.93; 0.98), between HL and myocardial infarction among women, and between HL and stroke among men. CONCLUSIONS: In this elderly general Eastern German population, we found higher HL score values compared with previous studies using the same questionnaire. HL was associated with socio-economic status. Furthermore, this cross-sectional study could show associations between HL and different health-related outcomes even after adjustment for educational level. However, further research is needed in order to evaluate the impact of HL on health-related outcomes using longitudinal data derived from the general population.
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Alfabetización en Salud , Población Urbana , Anciano , Anciano de 80 o más Años , Estudios Transversales , Diabetes Mellitus , Femenino , Alemania , Alfabetización en Salud/estadística & datos numéricos , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Infarto del Miocardio , Oportunidad Relativa , Estudios Prospectivos , Clase Social , Accidente Cerebrovascular , Encuestas y CuestionariosAsunto(s)
Presión Sanguínea , Hipertensión , Estudios de Cohortes , Alemania , Humanos , Vigilancia de la PoblaciónRESUMEN
OBJECTIVES: To evaluate the association between dinitrotoluene (DNT) exposure and renal cancer in a case-cohort study. METHODS: This case-cohort study was conducted among men born between 1920 and 1974 (n=16 441) who were gainfully employed between 1953 and 1990 in one of two copper mines in Mansfeld, Saxony-Anhalt, former German Democratic Republic, and followed up till 31 December 2006. The study included 109 cases with renal cancer identified by record linkage with the Common Cancer Registry of the New Federal States of Germany (GKR) or by a network of pathology institutes. A comparison subcohort of 999 cohort members was selected at random from the total cohort. Duration and intensity of inhalation and dermal exposure to DNT were assessed on the basis of a job exposure matrix. A time-dependent Cox proportional hazards model modified for case-cohort design was used to assess the relationship between cumulative inhalation and dermal DNT exposure and renal cancer. RESULTS: Elevated risks were found for medium (HR=2.73; 95% CI 1.00 to 7.42) and high (HR=1.81; 95% CI 0.75 to 4.33) dermal exposure to DNT. Relative risks for medium inhalation exposure to DNT were not increased (HR=0.93; 95% CI 0.48 to 1.79) while relative risks for high inhalation exposure to DNT were elevated to 1.36 (95% CI 0.84 to 2.21). We found a statistically significant HR of 2.12 (95% CI 1.03 to 4.37) for combined medium or high inhalation and medium or high dermal exposure to DNT. CONCLUSIONS: According to our case-cohort study, dermal and inhalation exposure to DNT is associated with increased renal cancer risk.
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Cobre , Neoplasias Renales/inducido químicamente , Minería , Enfermedades Profesionales/inducido químicamente , Exposición Profesional/efectos adversos , Tolueno/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Alemania , Humanos , Masculino , Persona de Mediana Edad , Modelos de Riesgos Proporcionales , Factores de Riesgo , Adulto JovenRESUMEN
BACKGROUND: The recently published German-Austrian S3 Guideline for the treatment of infarct related cardiogenic shock (CS) revealed a lack of evidence for all recommended therapeutic measures. OBJECTIVES: To determine the effects in terms of efficacy, efficiency and safety of cardiac care with inotropic agents and vasodilator strategies versus placebo or against each other for haemodynamic stabilisation following surgical treatment, interventional therapy (angioplasty, stent implantation) and conservative treatment (that is no revascularization) on mortality and morbidity in patients with acute myocardial infarction (AMI) complicated by CS or low cardiac output syndrome (LCOS). SEARCH METHODS: We searched CENTRAL, MEDLINE (Ovid), EMBASE (Ovid) and ISI Web of Science, registers of ongoing trials and proceedings of conferences in January 2013. Reference lists were scanned and experts in the field were contacted to obtain further information. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials in patients with AMI complicated by CS or LCOS. DATA COLLECTION AND ANALYSIS: Data collection and analysis were performed according to the published protocol. All trials were analysed individually. Hazard ratios (HRs) and odds ratios with 95% confidence intervals (CI) were extracted but not pooled because of high heterogeneity between the control group interventions. MAIN RESULTS: Four eligible, very small studies were identified from a total of 4065 references. Three trials with high overall risk of bias compared levosimendan to standard treatment (enoximone or dobutamine) or placebo. Data from a total of 63 participants were included in our comparisons, 31 were treated with levosimendan and 32 served as controls. Levosimendan showed an imprecise survival benefit in comparison with enoximone based on a very small trial with 32 participants (HR 0.33; 95% CI 0.11 to 0.97). Results from the other similarly small trials were too imprecise to provide any meaningful information about the effect of levosimendan in comparison with dobutamine or placebo. Only small differences in haemodynamics, length of hospital stay and the frequency of major adverse cardiac events or adverse events overall were found between study groups.Only one small randomised controlled trial with three participants was found for vasodilator strategies (nitric oxide gas versus placebo) in AMI complicated by CS or LCOS. This study was too small to draw any conclusions on the effects on our key outcomes. AUTHORS' CONCLUSIONS: At present there are no robust and convincing data to support a distinct inotropic or vasodilator drug based therapy as a superior solution to reduce mortality in haemodynamically unstable patients with CS or low cardiac output complicating AMI.
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Gasto Cardíaco Bajo/tratamiento farmacológico , Cardiotónicos/uso terapéutico , Infarto del Miocardio/complicaciones , Choque Cardiogénico/tratamiento farmacológico , Vasodilatadores/uso terapéutico , Gasto Cardíaco Bajo/etiología , Dobutamina/uso terapéutico , Enoximona/uso terapéutico , Humanos , Hidrazonas/uso terapéutico , Óxido Nítrico/uso terapéutico , Piridazinas/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como Asunto , Choque Cardiogénico/etiología , SimendánRESUMEN
BACKGROUND: Age and gender may be involved in the regulation of TSH and thyroid hormones. Reliable investigations concerned with the matter of whether or not these factors are of importance for diagnostic evaluation of the thyroid function are scarce. We used serum values of the CARLA study to calculate reference intervals for TSH, FT3, and FT4 and examine these parameters for their association with age or gender. METHODS: The CARLA study included 967 men and 812 women aged 45 to 83 years. We defined a reference group of 1002 subjects that were free of thyroid disease for data analysis by laboratory analysis and questionnaire, calculated age-dependent moving percentiles (2.5th/97.5th) for TSH, FT4, and FT3 and tested this data set for the confounding factors age and gender. Thereafter, the results were compared to data from the Leipzig Blood Donor study established in 2005. RESULTS: TSH (significant in trend (p = 0.064)) and FT3 (p = 0.001) were inversely associated with age. The correlation of FT3 with age was furthermore influenced by gender (p < 0.001). Neither gender nor age influenced values of FT4. CONCLUSIONS: The decreased TSH and FT3 levels with increasing age suggest a diagnostically relevant modification in the feed back regulation of thyroid function of the elderly. FT3 data should thus be interpreted gender-dependent and even age-dependent for males. These findings should be considered for the diagnostic examination of older patients with suspected disorders of thyroid function.
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Envejecimiento/sangre , Pruebas de Función de la Tiroides , Tirotropina/sangre , Tiroxina/sangre , Triyodotironina/sangre , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Femenino , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Valores de Referencia , Factores Sexuales , Adulto JovenRESUMEN
PURPOSE: Epidemiological and toxicological studies point to a potential carcinogenic effect of dinitrotoluene (DNT), particularly with respect to renal and urothelial cancer. METHODS: The cohort comprised all men born between 1920 and 1974 (n = 16,441) who were gainfully employed between 1953 and 1990 in one of two underground copper mines in Mansfeld, Saxony-Anhalt, former German Democratic Republic, and who were followed up for cancer incidence, 1961-2005. Incident cancer cases were identified by record linkage with the Common Cancer Registry of the New Laender. Standardized incidence ratios (SIR) were calculated with the general population of Saxony-Anhalt as the reference. RESULTS: Standardized incidence ratios for all cancers were not significantly elevated in the cohort (SIR = 1.04; 95 % confidence intervals (CI) 0.96-1.14). We found an increase in lung cancer (SIR = 1.29; 1.13-1.46), but not in kidney cancer (SIR = 1.01; 95 % CI 0.79-1.27) or bladder cancer (SIR = 1.04; 95 % CI 0.82-1.30). Standardized incidence ratios stratified by duration of employment with DNT exposure indicated moderately increased risks for kidney and bladder cancer in cohort members with longer exposure. CONCLUSIONS: The SIR analysis of workers in the copper mining industry in comparison with the general population of Saxony-Anhalt overall did not indicate increased risks for renal or bladder cancer. However, results by years of exposure to DNT suggested weakly increased risks for outcomes of a priori interest, bladder and kidney cancer. A subsequent case-cohort analysis including expert assessment of DNT exposure and identification of additional cancer cases from a network of pathology institutes will provide further insight into a potential etiologic role of DNT in renal and urothelial cancer.
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Carcinógenos/toxicidad , Dinitrobencenos/efectos adversos , Minería , Neoplasias/epidemiología , Enfermedades Profesionales/epidemiología , Exposición Profesional/efectos adversos , Adulto , Anciano , Anciano de 80 o más Años , Contaminantes Ocupacionales del Aire/efectos adversos , Estudios de Cohortes , Cobre , Alemania/epidemiología , Humanos , Incidencia , Neoplasias Renales/inducido químicamente , Neoplasias Renales/epidemiología , Masculino , Persona de Mediana Edad , Neoplasias/inducido químicamente , Enfermedades Profesionales/inducido químicamente , Neoplasias de la Vejiga Urinaria/inducido químicamente , Neoplasias de la Vejiga Urinaria/epidemiologíaRESUMEN
BACKGROUND: Heart rate variability (HRV), an important marker of autonomic nervous system activity, is usually determined from electrocardiogram (ECG) recordings corrected for extrasystoles and artifacts. Especially in large population-based studies, computer-based algorithms are used to determine RR intervals. The Modular ECG Analysis System MEANS is a widely used tool, especially in large studies. The aim of this study was therefore to evaluate MEANS for its ability to detect non-sinus ECG beats and artifacts and to compare HRV parameters in relation to ECG processing. Additionally, we analyzed how ECG processing affects the statistical association of HRV with cardiovascular disease (CVD) risk factors. METHODS: 20-min ECGs from 1,674 subjects of the population-based CARLA study were available for HRV analysis. All ECGs were processed with the ECG computer program MEANS. A reference standard was established by experienced clinicians who visually inspected the MEANS-processed ECGs and reclassified beats if necessary. HRV parameters were calculated for 5-minute segments selected from the original 20-minute ECG. The effects of misclassified typified normal beats on i) HRV calculation and ii) the associations of CVD risk factors (sex, age, diabetes, myocardial infarction) with HRV were modeled using linear regression. RESULTS: Compared to the reference standard, MEANS correctly classified 99% of all beats. The averaged sensitivity of MEANS across all ECGs to detect non-sinus beats was 76% [95% CI: 74.1;78.5], but for supraventricular extrasystoles detection sensitivity dropped to 38% [95% CI: 36.8;38.5]. Time-domain parameters were less affected by false sinus beats than frequency parameters. Compared to the reference standard, MEANS resulted in a higher SDNN on average (mean absolute difference 1.4ms [95% CI: 1.0;1.7], relative 4.9%). Other HRV parameters were also overestimated as well (between 6.5 and 29%). The effect estimates for the association of CVD risk factors with HRV did not differ between the editing methods. CONCLUSION: We have shown that the use of the automated MEANS algorithm may lead to an overestimation of HRV due to the misclassification of non-sinus beats, especially in frequency domain parameters. However, in population-based studies, this has no effect on the observed associations of HRV with risk factors, and therefore an automated ECG analyzing algorithm as MEANS can be recommended here for the determination of HRV parameters.
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Electrocardiografía , Frecuencia Cardíaca , Humanos , Frecuencia Cardíaca/fisiología , Electrocardiografía/métodos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Estudios de Cohortes , Algoritmos , Enfermedades Cardiovasculares/diagnóstico , Enfermedades Cardiovasculares/fisiopatología , Factores de RiesgoRESUMEN
BACKGROUND: Vascular-endothelial-growth-factor (VEGF) is a key mediator of angiogenesis. VEGF-targeting therapies have shown significant benefits and been successfully integrated in routine clinical practice for other types of cancer, such as metastatic colorectal cancer. By contrast, individual trial results in metastatic breast cancer (MBC) are highly variable and their value is controversial. OBJECTIVES: To evaluate the benefits (in progression-free survival (PFS) and overall survival (OS)) and harms (toxicity) of VEGF-targeting therapies in patients with hormone-refractory or hormone-receptor negative metastatic breast cancer. SEARCH METHODS: Searches of CENTRAL, MEDLINE, EMBASE, the Cochrane Breast Cancer Group's Specialised Register, registers of ongoing trials and proceedings of conferences were conducted in January and September 2011, starting in 2000. Reference lists were scanned and members of the Cochrane Breast Cancer Group, experts and manufacturers of relevant drug were contacted to obtain further information. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials (RCTs) to evaluate treatment benefit and non-randomised studies in the routine oncology practice setting to evaluate treatment harms. DATA COLLECTION AND ANALYSIS: We performed data collection and analysis according to the published protocol. Individual patient data was sought but not provided. Therefore, the meta-analysis had to be based on published data. Summary statistics for the primary endpoint (PFS) were hazard ratios (HRs). MAIN RESULTS: We identified seven RCTs, one register, and five ongoing trials from a total of 347 references. The published trials for VEGF-targeting drugs in MBC were limited to bevacizumab. Four trials, including a total of 2886 patients, were available for the comparison of first-line chemotherapy, with versus without bevacizumab. PFS (HR 0.67; 95% confidence interval (CI) 0.61 to 0.73) and response rate were significantly better for patients treated with bevacizumab, with moderate heterogeneity regarding the magnitude of the effect on PFS. For second-line chemotherapy, a smaller, but still significant benefit in terms of PFS could be demonstrated for patients treated with bevacizumab (HR 0.85; 95% CI 0.73 to 0.98), as well as a benefit in tumour response. However, OS did not differ significantly, neither in first- (HR 0.93; 95% CI 0.84 to 1.04), nor second-line therapy (HR 0.98; 95% CI 0.83 to 1.16). Quality of life (QoL) was evaluated in four trials but results were published for only two of these with no relevant impact. Subgroup analysis stated a significant greater benefit for patients with previous (taxane) chemotherapy and patients with hormone-receptor negative status. Regarding toxicity, data from RCTs and registry data were consistent and in line with the known toxicity profile of bevacizumab. While significantly higher rates of adverse events (AEs) grade III/IV (odds ratio (OR) 1.77; 95% CI 1.44 to 2.18) and serious adverse events (SAEs) (OR 1.41; 95% CI 1.13 to 1.75) were observed in patients treated with bevacizumab, rates of treatment-related deaths were lower in patients treated with bevacizumab (OR 0.60; 95% CI 0.36 to 0.99). AUTHORS' CONCLUSIONS: The overall patient benefit from adding bevacizumab to first- and second-line chemotherapy in metastatic breast cancer can at best be considered as modest. It is dependent on the type of chemotherapy used and limited to a prolongation of PFS and response rates in both first- and second-line therapy, both surrogate parameters. In contrast, bevacizumab has no significant impact on the patient-related secondary outcomes of OS or QoL, which indicate a direct patient benefit. For this reason, the clinical value of bevacizumab for metastatic breast cancer remains controversial.
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Inhibidores de la Angiogénesis/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Neoplasias de la Mama/irrigación sanguínea , Neoplasias de la Mama/tratamiento farmacológico , Neovascularización Patológica/tratamiento farmacológico , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores , Anciano , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bevacizumab , Supervivencia sin Enfermedad , Femenino , Humanos , Persona de Mediana Edad , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Intra-aortic balloon pump counterpulsation (IABP) is currently the most commonly used mechanical assist device for patients with cardiogenic shock due to acute myocardial infarction.Although there is only limited evidence by randomised controlled trials, the current guidelines of the American Heart Association/American College of Cardiology and the European Society of Cardiology strongly recommend the use of the intra-aortic balloon counterpulsation in patients with infarction-related cardiogenic shock on the basis of pathophysiological considerations as also non-randomised trials and registry data. OBJECTIVES: To determine the effect of IABP versus non-IABP or other assist devices guideline compliant standard therapy, in terms of efficacy and safety, on mortality and morbidity in patients with acute myocardial infarction complicated by cardiogenic shock. SEARCH STRATEGY: Searches of CENTRAL, MEDLINE and EMBASE, LILACS, IndMed and KoreaMed, registers of ongoing trials and proceedings of conferences were conducted in January 2010, unrestricted by date. Reference lists were scanned and experts in the field contacted to obtain further information. No language restrictions were applied. SELECTION CRITERIA: Randomised controlled trials on patients with myocardial infarction complicated by cardiogenic shock. DATA COLLECTION AND ANALYSIS: Data collection and analysis were performed according to a published protocol. Individual patient data were provided for five trials and merged with aggregate data. Summary statistics for the primary endpoints were hazard ratios (HR's) and odds ratios with 95% confidence intervals (CI). MAIN RESULTS: Six eligible and two ongoing studies were identified from a total of 1410 references. Three compared IABP to standard treatment and three to percutaneous left assist devices (LVAD). Data from a total of 190 patients with acute myocardial infarction and cardiogenic shock were included in the meta-analysis: 105 patients were treated with IABP and 85 patients served as controls. 40 patients were treated without assisting devices and 45 patients with LVAD. HR's for all-cause 30-day mortality of 1.04 (95% CI 0.62 to 1.73) provides no evidence for a survival benefit. While differences in survival were comparable in patients treated with IABP, with and without LVAD, haemodynamics and incidences of device related complications show heterogeneous results. AUTHORS' CONCLUSIONS: Available evidence suggests that IABP may have a beneficial effect on the haemodynamics, however there is no convincing randomised data to support the use of IABP in infarct related cardiogenic shock.
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Contrapulsador Intraaórtico/métodos , Infarto del Miocardio/complicaciones , Choque Cardiogénico/terapia , Humanos , Ensayos Clínicos Controlados Aleatorios como Asunto , Choque Cardiogénico/etiologíaRESUMEN
PURPOSE: Hypertension is one of the most relevant risk factors for cardiovascular disease; however, little is known about differences in hypertension by occupation. The aim of this study was to explore the association between occupational group and prevalent hypertension. METHODS: Cross-sectional data of the CARLA study were used, a representative sample of an East German population aged 45-83. Job titles of the current or last held occupation of 967 men and 808 women were coded using the German classification of occupation. Hypertension was defined as blood pressure of ≥140 mmHg (systolic), ≥90 mmHg (diastolic) or use of antihypertensives. Sex-stratified, age-adjusted prevalence risk ratios (PR) with 95% confidence intervals (CI) were calculated for 31 occupational groups. RESULTS: Hypertension was prevalent in 79% of the population. In men, highest age-adjusted prevalence ratios were observed in metal-processing workers, carpenters/painters, and electricians with PRs of 1.31 (CI 1.04-1.65), 1.28 (CI 1.00-1.64), and 1.21 (0.95-1.53), respectively, compared to office clerks. In women, highest PRs were found in technicians/forewomen, scrutinisers/storekeepers, and food-processing occupations with PR 1.28 (1.09-1.49), 1.23 (0.99-1.51), and 1.22 (1.01-1.48), respectively. Adjustment for education, smoking, body mass index, and current work hours did not fully explain occupational differences. Excluding currently non-working subjects lead to decreased PRs in men and to increased PR in women. CONCLUSIONS: Differences in the prevalences of hypertension by occupational group were only partly explained by conventional risk factors and may require workplace interventions targeted at high-risk occupations. Longitudinal data with large cohorts and work-related exposure assessment are needed to confirm a temporal relationship between occupation and incident hypertension.
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Hipertensión/epidemiología , Enfermedades Profesionales/epidemiología , Ocupaciones/clasificación , Anciano , Anciano de 80 o más Años , Presión Sanguínea/fisiología , Estudios de Cohortes , Estudios Transversales , Femenino , Alemania/epidemiología , Humanos , Hipertensión/etiología , Hipertensión/fisiopatología , Masculino , Persona de Mediana Edad , Enfermedades Profesionales/etiología , Ocupaciones/estadística & datos numéricos , Prevalencia , Factores de RiesgoRESUMEN
BACKGROUND: The influence of socioeconomic status (SES) on cardiovascular diseases and risk factors is widely known, although the role of different SES indicators is not fully understood. The aim of this study was to investigate the role of different SES indicators for cardiovascular disease risk factors in a middle and old aged East German population. METHODS: Cross-sectional data of an East German population-based cohort study (1779 men and women aged 45 to 83) were used to assess the association of childhood and adulthood SES indicators (childhood SES, education, occupational position, income) with cardiovascular risk factors. Adjusted means and odds ratios of risk factors by SES indicators with 95% confidence intervals (CI) were calculated by linear and logistic regression models, stratified by sex. The interaction effect of education and age on cardiovascular risk factors was tested by including an interaction term. RESULTS: In age-adjusted models, education, occupational position, and income were statistically significantly associated with abdominal obesity in men, and with smoking in both sexes. Men with low education had a more than threefold risk of being a smoker (OR 3.44, CI 1.58-7.51). Low childhood SES was associated with higher systolic blood pressure and abdominal obesity in women (OR 2.27, CI 1.18-4.38 for obesity); a non-significant but (in terms of effect size) relevant association of childhood SES with smoking was observed in men. In women, age was an effect modifier for education in the risk of obesity and smoking. CONCLUSIONS: We found considerable differences in cardiovascular risk factors by education, occupational position, income, and partly by childhood social status, differing by sex. Some social inequalities levelled off in higher age. Longitudinal studies are needed to differentiate between age and birth cohort effects.