Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,868
- 试验地点
- 1
- 主要终点
- Incidence of stroke or systemic embolism in the control group vs the intervention group
研究概览
简要总结
STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion
排除标准
- •Not fulfilling the inclusion criteria
结局指标
主要结局
Incidence of stroke or systemic embolism in the control group vs the intervention group
时间窗: Five years
Endpoints collected from the Swedish patient registry will be compared between the groups
Incidence of stroke or systemic embolism in the control group vs the low-risk group (with NT-proBNP<125 ng/L and normal index 1-lead ECG).
时间窗: Five years
Endpoints collected from the Swedish patient registry will be compared between the groups
次要结局
- Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.(Two years)
- Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group(Five years)
- Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.(Five years)
- To assess screening uptake with regards to socio-demographic factors and to study if we can improve uptake in the screening programme by decentralizing the recruitment procedure.(Two years)
- Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)(Five years)
- To assess the incidence of heart failure in patients with NT-proBNP>125ng/L(Five years)
- To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG(Four years)
- To study atrial function in patients with and without silent atrial fibrillation(Five years)
- To study the correlation between symptoms and newly discovered AF(Four years)
- To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF(Two years)
- To compare different ECG modalities for AF screening(Two years)
- Incidence of undiagnosed hypertension in participants(four years)
研究者
Professor Mårten Rosenqvist
Professor
Karolinska University Hospital
