跳至主要内容
临床试验/NCT05200676
NCT05200676已完成不适用

Cardiac Arrhythmias in Greenland

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Number of patients with ANS-neuropathy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Celiac disease (for the SmartPill-study)

结局指标

主要结局

Number of patients with ANS-neuropathy

时间窗: Within 10 months

Based on the recordings of the SmartPill-system. Data will be analysed externally by the MechSense-group at Aalborg University Hospital.

Prevalence od cardiac arrhythmiaa / atrial fibrillation in the population older than 50 years

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nadja Albertsen

Principal Investigator

Aalborg University Hospital

研究点 (1)

Loading locations...

相似试验