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临床试验/NCT02743416
NCT02743416Unknown不适用

Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II

Karolinska University Hospital1 个研究点 分布在 1 个国家目标入组 6,868 人开始时间: 2016年4月最近更新:
适应症

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

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

发起方
Karolinska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Professor Mårten Rosenqvist

Professor

Karolinska University Hospital

研究点 (1)

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