Atrial FibrillationNCT05200676
Cardiac Arrhythmias in Greenland
An observational study of Atrial Fibrillation and Arrhythmia, run by Aalborg University Hospital at 1 site in Greenland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atrial Fibrillation, Arrhythmia, Autonomic Neuropathy
- What is being tested?
- ePatch and SmartPill
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 200 participants
- Where
- 1 siteGreenland
- Study dates
- 16 Apr 2022to 11 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Study population: People aged 50 years or older living in Nuuk at the time of recruitment (January 2022) will be invited to participate. Ethnicity and eligibility will be assessed when contacting potential participants after the written invitation.
Who may be able to join
- At least 50 years old
- Greenlandic ethnicity based on parents' birth place.
- No history of cardiac disease or arrhythmia
Who cannot join
- Celiac disease (for the SmartPill-study)
Trial locations and contacts
1 site in 1 country.
Greenland1 site
Ilisimatusarfik
Nuuk, 3900
About this study
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation, Arrhythmia, Autonomic Neuropathy
- Being tested
- ePatch, SmartPill
- Medical subject headings
- Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ePatchDevice
ePatch registers the heart rate continuously when attached to the chest of the participant.
SmartPillDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Main group | All included in the study will offered to participate in:
* ePatch-monitoring
* Blood pressure measurement
* Cardial vagal tone
* Questionnaire-assessment Receives: Device: ePatch | |
| Subgroup | 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. Receives: Device: ePatch; Device: SmartPill |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Within 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start16 Apr 2022
- Primary completion28 Mar 2023
- Study completion11 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadja Albertsen, Aalborg University Hospital
- Investigators
- Nadja Albertsen, MD, PhD, Principal investigator, Aalborg University / University of Greenland and Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200676
- Sponsor's protocol ID
- KVUG 2020-18
- Status last verified
- Mar 2024
- First submitted
- 13 Dec 2021
- Last updated
- 15 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Arrhythmias in Greenland
- ClinicalTrials.gov ID
- NCT05200676
- Acronym / sponsor ID
- KVUG 2020-18
- Conditions
- Atrial Fibrillation, Arrhythmia, Autonomic Neuropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 11 Mar 2024 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Main group | – | Device: ePatchAll included in the study will offered to participate in: * ePatch-monitoring * Blood pressure measurement * Cardial vagal tone * Questionnaire-assessment |
| Subgroup | – | Device: ePatch, Device: SmartPillPart 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- People aged 50 years or older living in Nuuk at the time of recruitment (January 2022) will be invited to participate. Ethnicity and eligibility will be assessed when contacting potential participants after the written invitation.
Key inclusion criteria (3 listed)
- At least 50 years old
- Greenlandic ethnicity based on parents' birth place.
- No history of cardiac disease or arrhythmia
Key exclusion criteria (1 listed)
- Celiac disease (for the SmartPill-study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ePatchePatch registers the heart rate continuously when attached to the chest of the participant. | Device | Main group, Subgroup |
| SmartPillSmartPill 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. | Device | Subgroup |
Primary outcome
Prevalence od cardiac arrhythmiaa / atrial fibrillation in the population older than 50 years
Time frame: Completed within 6 months.
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.
Prevalence of common symptoms of arrhythmias
Time frame: Completed within 8 months
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.
Prevalence of risk factors for AF
Time frame: Completed within 8 months
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.
Number of patients with ANS-neuropathy
Time frame: Within 10 months
Based on the recordings of the SmartPill-system. Data will be analysed externally by the MechSense-group at Aalborg University Hospital.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadja Albertsen, MD, PhD principal investigator
Aalborg University / University of Greenland and Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Arrhythmia, run by Aalborg University Hospital at 1 site in Greenland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greenland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence od cardiac arrhythmiaa / atrial fibrillation in the population older than 50 years (time frame: Completed within 6 months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.