Non-invasive Monitoring for Early Detection of Atrial Fibrillation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-invasive Monitoring for Early Detection of Atrial Fibrillation

Conditions
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Atrial Fibrillation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 65 years Exclusion Criteria: age < 65 years

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 65 - 69 years<br>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<br>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<br>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<br>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<br>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<br>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 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Atrial fibrillation incidence in general population | the prevalence of atrial fibrillation | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart failure incidence | the prevalence of heart failure | 1 year | 
| Stroke incidence | the prevalence of stroke | 1 year | 
| Atrial hypertension incidence | the prevalence of arterial hypertension | 1 year | 
| Vascular diseases incidence | the prevalence of vascular diseases | 1 year |