Non-invasive Monitoring for Early Detection of Atrial Fibrillation

NCT03243474 | Completed

• 1 other identifier: NOMED-AF
• Study Type: observational
• Target: 3,014
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation incidence in general population

  the prevalence of atrial fibrillation

  1 year

Secondary Outcomes (4)

• Heart failure incidence

  1 year

• Stroke incidence

  1 year

• Atrial hypertension incidence

  1 year

• Vascular diseases incidence

  1 year

Study Arms (6)

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.

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

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

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

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

≥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

Eligibility Criteria

• Age: 65 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The survey was designed as a country representative study and was carried out on a sample of Polish residents aged ≥65 years, divided into six age groups of equal size and gender proportion (65-69, 70-74, 75-79, 80-84, 85-89 and 90+ years). The planned size of the research sample was 3,000 subjects (250 subjects for each gender and age group). Research participants were randomly recruited in clusters, in a stratified, proportional draw performed in three stages. The reason for overrepresentation of the oldest age groups was to allow separate analysis of data for older people.

You may qualify if:

• age ≥ 65 years

You may not qualify if:

• age \< 65 years

Sponsors & Collaborators

• Kardio-Med Silesia: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (7)

Medical University of Gdańsk

Gdansk, Poland

Location

Jagiellonian University - Medical College

Krakow, Poland

Location

Pomeranian Medical Uniwersity in Szczecin

Szczecin, Poland

Location

Comarch Healthcare

Warsaw, Poland

Location

Medical University of Warsaw

Warsaw, Poland

Location

Kardio-Med Silesia

Zabrze, 41-800, Poland

Location

Institute of Medical Technology and Equipment

Zabrze, Poland

Location

Related Publications (15)

• 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.

  PMID: 14715182 BACKGROUND

• 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.

  PMID: 23465249 BACKGROUND

• 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.

  PMID: 24130137 BACKGROUND

• 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.

  PMID: 12668495 BACKGROUND

• 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.

  PMID: 24281348 BACKGROUND

• 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.

  PMID: 22791299 BACKGROUND

• 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.

  PMID: 24685765 BACKGROUND

• 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.

  PMID: 23684685 BACKGROUND

• 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.

  PMID: 24360776 BACKGROUND

• 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.

  PMID: 12660385 BACKGROUND

• 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.

  PMID: 22922413 BACKGROUND

• 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.

  PMID: 23343564 BACKGROUND

• 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.

  PMID: 24351881 BACKGROUND

• Gumprecht J, Lip GYH, Sokal A, Sredniawa B, Stokwiszewski J, Zdrojewski T, Rutkowski M, Grodzicki T, Kazmierczak J, Opolski G, Kalarus Z. Impact of diabetes mellitus severity, treatment regimen and glycaemic control on atrial fibrillation prevalence in the Polish population aged >/= 65. Sci Rep. 2023 Oct 12;13(1):17252. doi: 10.1038/s41598-023-43939-5.

  PMID: 37828071 DERIVED

• 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.

  PMID: 34167520 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zbigniew Kalarus, Professor

  KardioMed Silesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 9, 2017
• Study Start: March 15, 2017
• Primary Completion: March 10, 2018
• Study Completion: March 10, 2019
• Last Updated: April 2, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share

Locations

PL (7)