Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 7,173
- 试验地点
- 2
- 主要终点
- Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
研究概览
简要总结
The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 76 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 75-76 years of age living in the region of Stockholm or Halland
排除标准
- •Not fulfilling the inclusion criteria
研究组 & 干预措施
ECG screening
Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks
干预措施: ECG screening for atrial fibrillation using intermittent ECG recorder (Other)
Control group
Standard of care
结局指标
主要结局
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
时间窗: Five years. Interim analysis after 3 years.
A composite endpoint of incidence of ischamemic and haemorrhagic stroke, incidence of systemic embolism, major bleeding requiring hospitalization and all cause mortality in the group randomized to screening compared to the control group
次要结局
- Hospitalization due to cardiovascular disease(Five years. Interim analysis after 3 years.)
- Ischaemic stroke(Five years. Interim analysis after 3 years.)
- All cause mortality(Five years. Interim analysis after 3 years.)
- Cardiovascular mortality(Five years. Interim analysis after 3 years.)
- Detection of atrial fibrillation(Five years)
- Pulmonary embolism and deep vein thrombosis(Five years)
- Dementia(Five years. Interim analysis after 3 years.)
- Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause(Five years. Interim analysis after 3 years.)
- Cost effectivity(Five years)
- Initiation and compliance to oral anticoagulation therapy(Five years)
- Ischaemic stroke and systemic thromboembolism(Five years. Interim analysis after 3 years.)
研究者
Professor Mårten Rosenqvist
Professor
Karolinska University Hospital