Non-invasive Monitoring for Early Detection of Atrial Fibrillation

March 30, 2019 updated by: Zbigniew Kalarus, Kardio-Med Silesia
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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

3014

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Gdańsk, Poland
        • Medical University of Gdansk
      • Kraków, Poland
        • Jagiellonian University - Medical College
      • Szczecin, Poland
        • Pomeranian Medical Uniwersity in Szczecin
      • Warszawa, Poland
        • Comarch Healthcare
      • Warszawa, Poland
        • Medical University of Warsaw
      • Zabrze, Poland, 41-800
        • Kardio-Med Silesia
      • Zabrze, Poland
        • Institute of Medical Technology and Equipment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 110 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • age ≥ 65 years

Exclusion Criteria:

  • age < 65 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kardio-Med Silesia

Collaborators

National Center for Research and Development, Poland

Investigators

  • Principal Investigator: Zbigniew Kalarus, Professor, KardioMed Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

March 10, 2018

Study Completion (Actual)

March 10, 2019

Study Registration Dates

First Submitted

August 1, 2017

First Submitted That Met QC Criteria

August 3, 2017

First Posted (Actual)

August 9, 2017

Study Record Updates

Last Update Posted (Actual)

April 2, 2019

Last Update Submitted That Met QC Criteria

March 30, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NOMED-AF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD that underlie results in a publication

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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