NCT05442970招募中不适用
An Epidemiologic, Prospective, Single Center Cohort Study for the Improvement of Atrial Fibrillation Risk Stratification in High Risk Individuals
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Incident atrial fibrillation
研究概览
简要总结
AFHRI is planned as a prospective, single-center cohort study in patients at high risk of AF.
详细描述
The primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, AF (paroxysmal or permanent).
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 85 years;
- •Personally signed informed consent
排除标准
- •Insufficient knowledge of the German language, in order to understand study documents and computer assisted interview without translation;
- •Physical or psychological incapability to cooperate in the investigations
结局指标
主要结局
Incident atrial fibrillation
时间窗: up to 4 years
12-lead Electrocardiogram (ECG) tracing, diagnosis of AF will be made if at least two cardiologists verify the rhythm abnormality using clinic visit, outside physician or hospital records, or ambulatory ECG reports.
次要结局
- Cardiovascular death(up to 4 years)
- Myocardial infarction(up to 4 years)
- Heart failure(up to 4 years)
研究者
研究点 (1)
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