Clinical trial NCT03243474: Non-invasive Monitoring for Early Detection of Atrial Fibrillation
Official title: Non-invasive Monitoring for Early Detection of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Kardio-Med Silesia
Sponsor class: OTHER
Collaborators: name: National Center for Research and Development, Poland
First posted: 2017-08-09
Enrollment: 3014
Sex: ALL
Minimum age (years): 65
Maximum age (years): 110
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* age ≥ 65 years

Exclusion Criteria:

* age \< 65 years

Primary outcomes:
measure: Atrial fibrillation incidence in general population
timeFrame: 1 year
Secondary outcomes:
measure: Heart failure incidence
timeFrame: 1 year
measure: Stroke incidence
timeFrame: 1 year
measure: Atrial hypertension incidence
timeFrame: 1 year
measure: Vascular diseases incidence
timeFrame: 1 year
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk
city: Kraków
country: Poland
facility: Jagiellonian University - Medical College
city: Szczecin
country: Poland
facility: Pomeranian Medical Uniwersity in Szczecin
city: Warszawa
country: Poland
facility: Comarch Healthcare
city: Warszawa
country: Poland
facility: Medical University of Warsaw
city: Zabrze
country: Poland
facility: Kardio-Med Silesia
city: Zabrze
country: Poland
facility: Institute of Medical Technology and Equipment
Study officials:
affiliation: KardioMed Silesia
name: Zbigniew Kalarus, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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