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Non-invasive Monitoring for Early Detection of Atrial Fibrillation

K

Kardio-Med Silesia

Status

Completed

Conditions

Atrial Fibrillation

Study type

Observational

Funder types

Other

Identifiers

NCT03243474
NOMED-AF

Details and patient eligibility

About

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

Full 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.

Enrollment

3,014 patients

Sex

All

Ages

65 to 110 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • age ≥ 65 years

Exclusion criteria

  • age < 65 years

Trial design

3,014 participants in 6 patient groups

65 - 69 years
Description:
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
Description:
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
Description:
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
Description:
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
Description:
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
Description:
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

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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