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Non-invasive Monitoring for Early Detection of Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT03243474
Recruitment Status : Completed
First Posted : August 9, 2017
Last Update Posted : April 2, 2019
Sponsor:
Collaborator:
National Center for Research and Development, Poland
Information provided by (Responsible Party):
Zbigniew Kalarus, Kardio-Med Silesia

Study Description
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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

Condition or disease
Atrial Fibrillation

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 Design
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Study Type : Observational
Actual Enrollment : 3014 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Non-invasive Monitoring for Early Detection of Atrial Fibrillation
Actual Study Start Date : March 15, 2017
Actual Primary Completion Date : March 10, 2018
Actual Study Completion Date : March 10, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Atrial fibrillation incidence in general population [ Time Frame: 1 year ]
    the prevalence of atrial fibrillation


Secondary Outcome Measures :
  1. Heart failure incidence [ Time Frame: 1 year ]
    the prevalence of heart failure

  2. Stroke incidence [ Time Frame: 1 year ]
    the prevalence of stroke

  3. Atrial hypertension incidence [ Time Frame: 1 year ]
    the prevalence of arterial hypertension

  4. Vascular diseases incidence [ Time Frame: 1 year ]
    the prevalence of vascular diseases


Eligibility Criteria
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Ages Eligible for Study:   65 Years to 110 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • age ≥ 65 years

Exclusion Criteria:

  • age < 65 years
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243474


Locations
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Poland
Medical University of Gdańsk
Gdańsk, Poland
Jagiellonian University - Medical College
Kraków, Poland
Pomeranian Medical Uniwersity in Szczecin
Szczecin, Poland
Comarch Healthcare
Warszawa, Poland
Medical University of Warsaw
Warszawa, Poland
Kardio-Med Silesia
Zabrze, Poland, 41-800
Institute of Medical Technology and Equipment
Zabrze, Poland
Sponsors and Collaborators
Kardio-Med Silesia
National Center for Research and Development, Poland
Investigators
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Principal Investigator: Zbigniew Kalarus, Professor KardioMed Silesia
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zbigniew Kalarus, Professor, Kardio-Med Silesia
ClinicalTrials.gov Identifier: NCT03243474    
Other Study ID Numbers: NOMED-AF
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes