Atrial Fibrillation Clinical Trial
Official title:
Non-invasive Monitoring for Early Detection of Atrial Fibrillation
NCT number | NCT03243474 |
Other study ID # | NOMED-AF |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2017 |
Est. completion date | March 10, 2019 |
Verified date | March 2019 |
Source | Kardio-Med Silesia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this project is to recognize the actual frequency of atrial fibrillation in the Polish population as well as to determine the independent risk factors for the occurrence of its clinically symptomatic and asymptomatic forms
Status | Completed |
Enrollment | 3014 |
Est. completion date | March 10, 2019 |
Est. primary completion date | March 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years to 110 Years |
Eligibility |
Inclusion Criteria: - age = 65 years Exclusion Criteria: - age < 65 years |
Country | Name | City | State |
---|---|---|---|
Poland | Medical University of Gdansk | Gdansk | |
Poland | Jagiellonian University - Medical College | Kraków | |
Poland | Pomeranian Medical Uniwersity in Szczecin | Szczecin | |
Poland | Comarch Healthcare | Warszawa | |
Poland | Medical University of Warsaw | Warszawa | |
Poland | Institute of Medical Technology and Equipment | Zabrze | |
Poland | Kardio-Med Silesia | Zabrze |
Lead Sponsor | Collaborator |
---|---|
Kardio-Med Silesia | National Center for Research and Development, Poland |
Poland,
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. Erratum in: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1. — View Citation
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. — View Citation
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. — View Citation
Fernandez V, Béjot 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. — View Citation
Friberg L, Engdahl J, Frykman V, Svennberg E, Levin LÅ, 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. — View Citation
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. Epub 2003 Mar 24. — View Citation
Grond M, Jauss M, Hamann G, Stark E, Veltkamp R, Nabavi D, Horn M, Weimar C, Köhrmann 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. — View Citation
Israel CW, Grönefeld 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. Review. — View Citation
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. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Atrial fibrillation incidence in general population | the prevalence of atrial fibrillation | 1 year | |
Secondary | Heart failure incidence | the prevalence of heart failure | 1 year | |
Secondary | Stroke incidence | the prevalence of stroke | 1 year | |
Secondary | Atrial hypertension incidence | the prevalence of arterial hypertension | 1 year | |
Secondary | Vascular diseases incidence | the prevalence of vascular diseases | 1 year |
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