Cardiac Arrhythmias in Greenland

Study Overview
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Brief Summary
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The study is a phd-study comprising several substudies focusing on cardiac arrhythmias, mainly atrial fibrillation, among Greenlanders in Greenland. Some previous studies have indicated that the prevalence may be lower than among Westerners, however; studies have also indicated that atrial fibrillation is underdiagnosed. These studies aim to: Estimate the prevalence of AF among Greenlanders in Greenland aged 55 years or older. Estimate the prevalence of well-known risk factors among those found to have AF Explore the symptoms of those affected by AF in Greenland Among part of the participants: estimate the prevalence of autonomic neuropathy as this may cause arrhythmias.

Detailed Description
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Atrial fibrillation (AF) is the most common cardiac arrhythmia globally and a major risk factor for ischemic strokes, transient ischemic attacks, increased morbidity and mortality. Risk factors for AF include diabetes, hyperthyroidism, hypertension, obesity, ischemic heart disease (IHD), age and gender with men generally having a higher risk of developing AF. The current prevalence of cardiac arrhythmias in Greenland is unknown. From 1962 to 1964 12-lead electrocardiograms (ECGs) were performed on 181 adults and only one of these showed AF. A more recent study from 2013 estimating the incidence of ischemic strokes among Greenlanders found that five percent of this study-population had been diagnosed with AF before the incident, while 32.4 % were diagnosed after the incident, suggesting that AF may be underdiagnosed. Comparing the age of the patients to data from Denmark, the authors found that the incidence rate for stroke was higher among almost all younger age groups in Greenland. Previous studies have shown that ethnicity may influence the risk of developing AF. The genetic profile of the Greenlandic Inuit has already been shown to have a major impact on the risk of developing type 2 diabetes. Regarding other AF-related risk factors, hypertension is common with a prevalence of app. 40% among men and 32% among women based on self-reported data, and a study comparing data from ECGs performed in 1963 with more current data has shown a rise in the incidence of IHD. Furthermore, the number of obese people in Greenland is steadily rising and between 1963 and 2008, the proportion of obese people (BMI≥30) increased from 4.0% to 33.2% for men and 8.3% to 24.5% for women between 50 to 69 years. In conclusion, the risk factors for cardiac arrhythmias are increasing in Greenland and the overall aim of this study is to estimate the prevalence, risk factors, mortality, morbidity and treatment of arrhythmias in Greenland. Relevance: as mentioned above, this study aims to estimate the prevalence, risk factors, mortality, morbidity and treatment of arrhythmias in Greenland, all of which is currently unknown. By doing this, the study aims to not only improve the treatment rate of arrhythmias, but also lower the prevalence of diseases such as strokes, which are often caused by arrhythmias. By lowering this prevalence, some deaths and cases of disability can be prevented. Furthermore, the investigators hope to assess whether arrhythmias are influenced differently by ethnicity and risk factors such as diabetes in Greenland than in Europe and if patients with certain diseases and/or symptoms have a higher risk of developing arrhythmias and should be monitored more closely.

Official Title
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Cardiac Arrhythmias in Greenland

Conditions
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Atrial Fibrillation, Arrhythmia, Autonomic Neuropathy

Intervention / Treatment
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* Device: ePatch
* Device: SmartPill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 50 years old Greenlandic ethnicity based on parents' birth place. No history of cardiac disease or arrhythmia Exclusion Criteria: Celiac disease (for the SmartPill-study)

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main group<br>All included in the study will offered to participate in: ePatch-monitoring Blood pressure measurement Cardial vagal tone Questionnaire-assessment | Device: ePatch<br>* ePatch registers the heart rate continuously when attached to the chest of the participant.<br>|
| Subgroup<br>Part of the study-population will be offered to participate in en examination with a SmartPill. The Smartpill measures pressure, pH, temperature and movement in the gut. These measurements gives an indication of the function of the autonomic nervous system (ANS) of the participant. Although measured in the gut, this is relevant as ANS-dysfunction may cause arrhythmias. Only a subgroup of the study population will be offered to participate due to the cost of this examination. | Device: ePatch<br>* ePatch registers the heart rate continuously when attached to the chest of the participant.<br>Device: SmartPill<br>* SmartPill is swallowed and passes through the digestive system while sending information to a recording device. The pill is passed in the stool and not reused.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence od cardiac arrhythmiaa / atrial fibrillation in the population older than 50 years | Whether participant has an arrhythmia or not - and if the participant does, what kind of arrhythmia. ePatch recordings will be analysed by the producing company after the completion of the recordings of all participants. | Completed within 6 months. | 
| Prevalence of common symptoms of arrhythmias | Questionnaire-based. Participants will be asked about the most common symptoms of arrhythmias (palpitations, chest pains, feeling a loss of a beat, dizziness). Depending on the results, the questionnaires may be followed-up by qualitative interviews. The questionnaires are filled out as part of the trial. Results will be entered into a database (RedCap) continuously and analysed after the trial. | Completed within 8 months | 
| Prevalence of risk factors for AF | Questionnaire-based. Participants will be asked about common risk factors for AF (family history, smoking, hypertension, ischemic heart disease, thyroid disease, age, gender). The questionnaires are filled out as part of the trial. Results will be entered into a database (RedCap) continuously and analysed after the trial. | Completed within 8 months | 
| Number of patients with ANS-neuropathy | Based on the recordings of the SmartPill-system. Data will be analysed externally by the MechSense-group at Aalborg University Hospital. | Within 10 months |