Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Burden of Illness in Atrial Fibrillation

4 de febrero de 2016 actualizado por: Bayer

Burden of Illness in Atrial Fibrillation in Denmark

The overall goal of this retrospective registry study is to investigate the burden-of.illness in atrial fibrillation (AF) in Denmark. Several Danish registries will be utilized to collect information on the diseases epidemiology including incidence and prevalence of AF and stroke as well as a stroke risk stratification of the Danish AF-population, the clinical and economical burden (in terms of direct and indirect cost) of AF and stroke to Danish patients, healthcare providers / healthcare system and society as well as describing treatment patterns with anticoagulant agents and their consequences in terms of stroke, bleeds, death and according cost in a real-life setting.

Descripción general del estudio

Estado

Terminado

Condiciones

Fibrilación auricular

Intervención / Tratamiento

Droga: Standard of care in AF in Denmark

Tipo de estudio

De observación

Inscripción (Actual)

107532

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Dinamarca
- - Many Locations, Dinamarca

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 90 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.

Descripción

Inclusion Criteria:

Primary and secondary diagnosis with AF;
The base population of AF patients will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code (ICD10-code: DI480, DI481, DI482, DI483, DI484, DI489) will be included.

Exclusion Criteria:

Patients younger than 18 and older than 90 years of age.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Número de grupos/cohortes

Cohortes e Intervenciones

Grupo / Cohorte	Intervención / Tratamiento
AF patients in Denmark / Cohort 1 The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified. Further Data sources used: Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender	Droga: Standard of care in AF in Denmark As used in clinical practice, analysed as per drug class, not separate drugs.

Grupo / Cohorte

Intervención / Tratamiento

AF patients in Denmark / Cohort 1

The base population of AF patients for diagnosis and health care utilization / resource use will be identified in the National Patient Registry. For a given period of time (2000-2013, both years inclusive) all patients with a hospital contact (admission, outpatient visit or ER visit) and for whom AF was the primary or secondary diagnosis code will be identified.

Further Data sources used:

Registry of Medicinal Product Statistics: for determining the individuals' use of prescription medicine DREAM database: for investigation of sickness benefit and productivity loss Statistics Denmark's databases: on social services from municipalities Cause of Death Registry: AF-patients or controls who died during the study period (2000-2013) Danish Civil Registry: used for identification of controls, holds information about age, gender

Droga: Standard of care in AF in Denmark

As used in clinical practice, analysed as per drug class, not separate drugs.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Number of patients with (non-valvular) AF in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year in total Danish population and by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients with (non-valvular) AF per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with (non-valvular) AF per year and per Danish Region and by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Mortality among AF patients compared with that of the general population/the 'controls', if possible by gender and age group Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients with stroke in (non-valvular) AF-patients in Denmark by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of newly diagnosed patients with stroke in (non-valvular) AF-patients per year in Denmark by gender and age groups 18-65, 66-75, 75+, 80+ Periodo de tiempo: up to 4 weeks		up to 4 weeks
Mortality among stroke patients (in AF) compared with that of the population/the 'controls' and the total AF-population, if possible by gender and age group Periodo de tiempo: up to 4 weeks		up to 4 weeks
Direct cost in AF (in total and per patient) Periodo de tiempo: up to 4 weeks	Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Direct cost in AF-related stroke (in total and per patient) Periodo de tiempo: up to 4 weeks	Costs due to: Patients' resource use in the primary care sector (GP-visits, etc.) Patients' resource use in the hospital sector, including specialized rehabilitation Patients' use of prescription medicine Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Indirect cost in AF (in total and per patient) Periodo de tiempo: up to 4 weeks	Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks
Indirect cost in AF-related stroke (in total and per patient) Periodo de tiempo: up to 4 weeks	Costs due to: Patients' long-term absence from the labour force (only relevant for patients under 65 years of age) Patients' demand for home care and rehabilitation delivered by municipalities Cost will be shown: For Denmark Per Region including differences between Regions For differentiation by age group For differentiation by Region and age group, if possible based on sample sizes	up to 4 weeks

Medidas de resultado secundarias

Medida de resultado	Medida Descripción	Periodo de tiempo
Number of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population Periodo de tiempo: up to 4 weeks	CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)	up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CHADS2-score (0 to 6) in Danish population Periodo de tiempo: up to 4 weeks	CHADS2-score: Congestive heart failure/left ventricular dysfunction, Hypertension, Age, Diabetes, Stroke (Doubled)	up to 4 weeks
Number of patients with AF-related stroke rated per average CHADS-score in Danish population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish populationPercentage (%) of patients with AF-related stroke rated per average CHADS-score in Danish population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients with AF-related stroke rated per CH2ADS2-VASc-score (0 to 9) in Danish population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients per HAS-BLED-score (0 to 9) in Danish AF-population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients per HAS-BLED-score (0 to 9) in Danish AF-population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients per average HAS-BLED-score in Danish AF-population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients per average HAS-BLED-score in Danish AF-population Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving warfarin Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients in total and per CH2ADS2-VASc-score receiving no treatment Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Acetylsalicylic Acid [ASA] Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving Warfarin Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving any Novel Oral Anticoagulants [NOACs] Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients in total and per CH2ADS2-VASc-score receiving no treatment Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per anticoagulant agent (AC)-medication incl. no treatment in total Periodo de tiempo: up to 4 weeks		up to 4 weeks
Number of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score Periodo de tiempo: up to 4 weeks		up to 4 weeks
Percentage (%) of patients experiencing events (e.g. stroke, Systemic Embolism [SE], Myocardial Infarction [MI], bleeds, death) since AF-diagnosis per Anticoagulant agent (AC)-medication incl. no treatment per CHADS-VASc-score Periodo de tiempo: up to 4 weeks		up to 4 weeks
Vitamin K antagonist (VKA) treated AF-patients in AC-clinics versus GP-setting Periodo de tiempo: up to 4 weeks	Based on data from the National Patient Registry, the Primary Care Registry and the Registry of Medicinal Product Statistics and inclusion codes for specific fees/services, it will be possible to identify which patients are treated in an AC-clinic and which patients are treated in a GP-setting	up to 4 weeks
Direct and indirect cost of AC medication treatment patterns Periodo de tiempo: up to 4 weeks		up to 4 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Bayer

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2015

Finalización primaria (Actual)

1 de diciembre de 2015

Finalización del estudio (Actual)

1 de diciembre de 2015

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2015

Primero enviado que cumplió con los criterios de control de calidad

25 de noviembre de 2015

Publicado por primera vez (Estimar)

26 de noviembre de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

5 de febrero de 2016

Última actualización enviada que cumplió con los criterios de control de calidad

4 de febrero de 2016

Última verificación

1 de febrero de 2016

Más información

Términos relacionados con este estudio

Palabras clave

fibrilación auricular no valvular

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

18313

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Fibrilación auricular

The Second Affiliated Hospital of Chongqing Medical...

Terminado

Agrandamiento de la aurícula izquierda: un indicador crucial para identificar la fibrilación auricular en pacientes con hipertensión

Fibrilación auricular | Hipertensión,Esencial | Dilatación atrial izquierda

Porcelana
Region Skane

Reclutamiento

Ablación del nódulo AV y marcapasos de His versus aislamiento de la vena pulmonar para la fibrilación auricular (His-PAAF)

Fibrilación auricular | Dilatación atrial izquierda

Suecia
Wake Forest University Health Sciences
National Heart, Lung, and Blood Institute (NHLBI)

Reclutamiento

Hipertensión pediátrica y el sistema renina-angiotensina (FRASE) (PHRASE)

Enfermedades Renales | Hipertensión | Obesidad Pediátrica | Proteinuria | Albuminuria | Lesión renal | Trastornos de la presión arterial | Disfunción autonómica | Enfermedad renal pediátrica | Disfunción Ventricular Izquierda | Hipertrofia del ventrículo izquierdo | Disfunción renal | Desequilibrio autonómico | Disfunción... y otras condiciones

Estados Unidos

Ensayos clínicos sobre Standard of care in AF in Denmark

RapidPulse, Inc

Terminado

Estudio de viabilidad del sistema de aspiración RapidPulseTM como enfoque de primera línea para pacientes con accidente cerebrovascular (RapidPulseFS)

Accidente cerebrovascular isquémico agudo

Dinamarca, Letonia, Pavo, Brasil, España
University of Alberta
Public Health Agency of Canada (PHAC)

Terminado

Apoyo a los cuidadores familiares de personas que viven con demencia: eficacia y sostenibilidad de MT4C-In Care

Demencia | Familia

Canadá
University of Hawaii
National Institute on Minority Health and Health Disparities (NIMHD)

Terminado

Partners in Care con grupo de apoyo semiestructurado

Diabetes Mellitus, Tipo 2

Estados Unidos
Kettering Health Network

Terminado

Efecto de la matriz para heridas Oasis® en las heridas por presión en el tronco en estadio III y IV tratadas con terapia de heridas con presión negativa

Pared Abdominal Herida Abierta | Herida que no cicatriza

Estados Unidos
DeRoyal Industries, Inc.
Lincoln Memorial University

Terminado

Estudio que compara el efecto de los apósitos y dispositivos iNPWT en los niveles de biocarga y el estado de la piel después de siete días (HHiNPWT7DC)

Sensibilización de la piel | Reacción de la piel a estímulos mecánicos, térmicos y de radiación

Estados Unidos
Hospital Clínico Universitario de Valladolid

Reclutamiento

Estudio NUMITOR: estudio ibérico de cefalea numular sobre tratamientos y resultados en entornos reales (NUMITOR)

Enfermedades Cerebrales | Enfermedades del Sistema Nervioso Central | Enfermedades del Sistema Nervioso | Dolor | Manifestaciones neurológicas | Trastornos de dolor de cabeza | Trastornos de Cefalea, Secundaria

España
Charles Drew University of Medicine and Science

Retirado

Atención de la obesidad infantil informada sobre el trauma para minorías de bajos ingresos en atención primaria

Obesidad infantil
World Bank
Addis Ababa University; Ethiopian Medical Association; Policy Studies Institute

Reclutamiento

Abordar el estrés entre las mujeres empresarias en Etiopía - Ampliar

Estrés | Regulación emocional | Estrés mental | Violencia de Género | Estrés, trabajo | Problemas económicos

Etiopía
University of Arizona

Desconocido

Catéter pigtail versus tubo torácico en el tratamiento del neumotórax traumático

Neumotórax traumático

Estados Unidos
H. Lee Moffitt Cancer Center and Research Institute
Servier

Reclutamiento

CalPeg para la leucemia linfoblástica aguda (LLA) recién diagnosticada

Leucemia linfoblástica aguda

Estados Unidos

Burden of Illness in Atrial Fibrillation