跳至主要内容
临床试验/NCT03243474
NCT03243474已完成不适用

Non-invasive Monitoring for Early Detection of Atrial Fibrillation

Kardio-Med Silesia7 个研究点 分布在 1 个国家目标入组 3,014 人开始时间: 2017年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
3,014
试验地点
7
主要终点
Atrial fibrillation incidence in general population

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

入排标准

年龄范围
65 Years 至 110 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥ 65 years

排除标准

  • age < 65 years

结局指标

主要结局

Atrial fibrillation incidence in general population

时间窗: 1 year

the prevalence of atrial fibrillation

次要结局

  • Heart failure incidence(1 year)
  • Stroke incidence(1 year)
  • Atrial hypertension incidence(1 year)
  • Vascular diseases incidence(1 year)

研究者

发起方
Kardio-Med Silesia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zbigniew Kalarus

Professor

Kardio-Med Silesia

研究点 (7)

Loading locations...

相似试验