Cardiac Arrhythmias in Greenland

NCT05200676 | Completed

• 1 other identifier: KVUG 2020-18
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Atrial Fibrillation; Arrhythmia; Autonomic Neuropathy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Main group

All included in the study will offered to participate in: * ePatch-monitoring * Blood pressure measurement * Cardial vagal tone * Questionnaire-assessment

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.

Device: ePatch; Device: SmartPill

Interventions

ePatch DEVICE

ePatch registers the heart rate continuously when attached to the chest of the participant.

Main group; Subgroup

SmartPill DEVICE

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.

Subgroup

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• At least 50 years old
• Greenlandic ethnicity based on parents' birth place.
• No history of cardiac disease or arrhythmia

You may not qualify if:

• Celiac disease (for the SmartPill-study)

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Ilisimatusarfik

Nuuk, 3900, Greenland

Location

MeSH Terms

Conditions

Atrial Fibrillation; Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadja Albertsen, MD, PhD

  Aalborg University / University of Greenland and Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: January 21, 2022
• Study Start: April 16, 2022
• Primary Completion: March 28, 2023
• Study Completion: March 11, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)