- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03243474
Non-invasive Monitoring for Early Detection of Atrial Fibrillation
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The AF Survey is a cross-sectional observational study aimed to assess the prevalence and control of AF and its correlation with CVD risk factors in Poland, based on a representative sample of adults aged 65+. The main aim of the survey is to assess the prevalence, detectability and control of AF, heart failure, vascular diseases, arterial hypertension, stroke, sedentary lifestyle, smoking, lipid disorders, metabolic syndrome, obesity and diabetes, as well as other factors related to CVD risk such as chronic kidney and liver diseases, sleeping disorders, depression and selected psychosocial factors.
The assessment of AF prevalence with use of the monitoring system developed and validated during the first phase of the project, would be composed of a questionnaire, follow-up data sheet, blood pressure (BP) measurements and a blood sample collection.
The survey consists of three visits to subjects' homes (day: 1; 10+/-4 days and 30+/-4 days) and one phone contact one year after first visit and would be performed by trained nurses. The monitoring system would be installed during the first visit for all patients who sign informed consent form and returned at the third visit one month later. The main questionnaire will be completed during the first visit, which included detailed questions about present health status and history of diseases, hospitalizations, and current medications. The socioeconomic part of the questionnaire included questions concerning the personal and family situation, economic status, household structure, leisure activities, hobbies, and social life. During this visit the Geriatric scale of depression evaluation will be given to the subject to be self-completed, and will be collected at the second visit. BP readings would be taken three times during each visit to the patient's home. Anthropometric measurements are taken twice: at visit one and visit three at the end of the ECG monitoring. Blood samples are taken from subjects at the second visit after 10 to 12-hour fasting. The follow-up data sheet would be completed at the initial visit and at the follow-up visit twelve months after inclusion to the survey. The fieldwork is subcontracted to a company specializing in market research projects for the private and public sectors. The transportation of biological material to the Central Laboratory has been subcontracted to a company with expertise in blood sample transport over long distances. Interviewers will be recruited from among professionally active nurses. Most of them will be social nurses working within local communities. All nurses participating in the survey will complete special training prepared for fieldwork executors of the NOMED-AF project.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Gdańsk, Polonia
- Medical University of Gdansk
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Kraków, Polonia
- Jagiellonian University - Medical College
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Szczecin, Polonia
- Pomeranian Medical Uniwersity in Szczecin
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Warszawa, Polonia
- Comarch Healthcare
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Warszawa, Polonia
- Medical University of Warsaw
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Zabrze, Polonia, 41-800
- Kardio-Med Silesia
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Zabrze, Polonia
- Institute of Medical Technology and Equipment
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- age ≥ 65 years
Exclusion Criteria:
- age < 65 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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65 - 69 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged 65 - 69 years.
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70 - 74 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged 70 - 74 years
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75- 79 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged 75 - 79 years
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80 - 84 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged 80 - 84 years
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85 - 89 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged 85- 89 years
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≥90 years
The assessment of AF prevalence with use of the monitoring system, blood pressure (BP) measurements and a blood sample collection in patients aged ≥90 years
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Atrial fibrillation incidence in general population
Periodo de tiempo: 1 year
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the prevalence of atrial fibrillation
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1 year
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart failure incidence
Periodo de tiempo: 1 year
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the prevalence of heart failure
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1 year
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Stroke incidence
Periodo de tiempo: 1 year
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the prevalence of stroke
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1 year
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Atrial hypertension incidence
Periodo de tiempo: 1 year
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the prevalence of arterial hypertension
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1 year
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Vascular diseases incidence
Periodo de tiempo: 1 year
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the prevalence of vascular diseases
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1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Zbigniew Kalarus, Professor, KardioMed Silesia
Publicaciones y enlaces útiles
Publicaciones Generales
- Israel CW, Gronefeld G, Ehrlich JR, Li YG, Hohnloser SH. Long-term risk of recurrent atrial fibrillation as documented by an implantable monitoring device: implications for optimal patient care. J Am Coll Cardiol. 2004 Jan 7;43(1):47-52. doi: 10.1016/j.jacc.2003.08.027.
- Vermeer SE, Prins ND, den Heijer T, Hofman A, Koudstaal PJ, Breteler MM. Silent brain infarcts and the risk of dementia and cognitive decline. N Engl J Med. 2003 Mar 27;348(13):1215-22. doi: 10.1056/NEJMoa022066.
- Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available. Erratum In: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1.
- Glotzer TV, Hellkamp AS, Zimmerman J, Sweeney MO, Yee R, Marinchak R, Cook J, Paraschos A, Love J, Radoslovich G, Lee KL, Lamas GA; MOST Investigators. Atrial high rate episodes detected by pacemaker diagnostics predict death and stroke: report of the Atrial Diagnostics Ancillary Study of the MOde Selection Trial (MOST). Circulation. 2003 Apr 1;107(12):1614-9. doi: 10.1161/01.CIR.0000057981.70380.45. Epub 2003 Mar 24.
- Marfella R, Sasso FC, Siniscalchi M, Cirillo M, Paolisso P, Sardu C, Barbieri M, Rizzo MR, Mauro C, Paolisso G. Brief episodes of silent atrial fibrillation predict clinical vascular brain disease in type 2 diabetic patients. J Am Coll Cardiol. 2013 Aug 6;62(6):525-30. doi: 10.1016/j.jacc.2013.02.091. Epub 2013 May 15.
- Lau JK, Lowres N, Neubeck L, Brieger DB, Sy RW, Galloway CD, Albert DE, Freedman SB. iPhone ECG application for community screening to detect silent atrial fibrillation: a novel technology to prevent stroke. Int J Cardiol. 2013 Apr 30;165(1):193-4. doi: 10.1016/j.ijcard.2013.01.220. Epub 2013 Mar 7. No abstract available.
- Grond M, Jauss M, Hamann G, Stark E, Veltkamp R, Nabavi D, Horn M, Weimar C, Kohrmann M, Wachter R, Rosin L, Kirchhof P. Improved detection of silent atrial fibrillation using 72-hour Holter ECG in patients with ischemic stroke: a prospective multicenter cohort study. Stroke. 2013 Dec;44(12):3357-64. doi: 10.1161/STROKEAHA.113.001884. Epub 2013 Oct 15.
- Quinn FR, Gladstone D. Screening for undiagnosed atrial fibrillation in the community. Curr Opin Cardiol. 2014 Jan;29(1):28-35. doi: 10.1097/HCO.0000000000000018.
- Friberg L, Engdahl J, Frykman V, Svennberg E, Levin LA, Rosenqvist M. Population screening of 75- and 76-year-old men and women for silent atrial fibrillation (STROKESTOP). Europace. 2013 Jan;15(1):135-40. doi: 10.1093/europace/eus217. Epub 2012 Jul 11.
- Fernandez V, Bejot Y, Zeller M, Hamblin J, Daubail B, Jacquin A, Maza M, Touzery C, Cottin Y, Giroud M. Silent atrial fibrillation after ischemic stroke or transient ischemic attack: interest of continuous ECG monitoring. Eur Neurol. 2014;71(5-6):313-8. doi: 10.1159/000357561. Epub 2014 Mar 26.
- Cha MJ, Park HE, Lee MH, Cho Y, Choi EK, Oh S. Prevalence of and risk factors for silent ischemic stroke in patients with atrial fibrillation as determined by brain magnetic resonance imaging. Am J Cardiol. 2014 Feb 15;113(4):655-61. doi: 10.1016/j.amjcard.2013.11.011. Epub 2013 Nov 23.
- Engdahl J, Andersson L, Mirskaya M, Rosenqvist M. Stepwise screening of atrial fibrillation in a 75-year-old population: implications for stroke prevention. Circulation. 2013 Feb 26;127(8):930-7. doi: 10.1161/CIRCULATIONAHA.112.126656. Epub 2013 Jan 23.
- Lip GY, Laroche C, Dan GA, Santini M, Kalarus Z, Rasmussen LH, Oliveira MM, Mairesse G, Crijns HJ, Simantirakis E, Atar D, Kirchhof P, Vardas P, Tavazzi L, Maggioni AP. A prospective survey in European Society of Cardiology member countries of atrial fibrillation management: baseline results of EURObservational Research Programme Atrial Fibrillation (EORP-AF) Pilot General Registry. Europace. 2014 Mar;16(3):308-19. doi: 10.1093/europace/eut373. Epub 2013 Dec 17. Erratum In: Europace. 2014 Jun;16(6):941.
- Gumprecht J, Lip GYH, Sokal A, Sredniawa B, Mitrega K, Stokwiszewski J, Wierucki L, Rajca A, Rutkowski M, Zdrojewski T, Grodzicki T, Kazmierczak J, Opolski G, Kalarus Z. Relationship between diabetes mellitus and atrial fibrillation prevalence in the Polish population: a report from the Non-invasive Monitoring for Early Detection of Atrial Fibrillation (NOMED-AF) prospective cross-sectional observational study. Cardiovasc Diabetol. 2021 Jun 24;20(1):128. doi: 10.1186/s12933-021-01318-2.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NOMED-AF
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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