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Non-invasive Monitoring for Early Detection of Atrial Fibrillation

30. marts 2019 opdateret af: 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

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3014

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år til 110 år (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • age ≥ 65 years

Exclusion Criteria:

  • age < 65 years

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Atrial fibrillation incidence in general population
Tidsramme: 1 year
the prevalence of atrial fibrillation
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Heart failure incidence
Tidsramme: 1 year
the prevalence of heart failure
1 year
Stroke incidence
Tidsramme: 1 year
the prevalence of stroke
1 year
Atrial hypertension incidence
Tidsramme: 1 year
the prevalence of arterial hypertension
1 year
Vascular diseases incidence
Tidsramme: 1 year
the prevalence of vascular diseases
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Zbigniew Kalarus, Professor, KardioMed Silesia

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. marts 2017

Primær færdiggørelse (Faktiske)

10. marts 2018

Studieafslutning (Faktiske)

10. marts 2019

Datoer for studieregistrering

Først indsendt

1. august 2017

Først indsendt, der opfyldte QC-kriterier

3. august 2017

Først opslået (Faktiske)

9. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. marts 2019

Sidst verificeret

1. marts 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NOMED-AF

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

all IPD that underlie results in a publication

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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