Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 2
- 主要终点
- Number of participants with the composite outcome of ischemic stroke or cardiovascular death
研究概览
简要总结
The aim is to investigate whether screening with long-term ECG monitoring in individuals with elevated NT-proBNP leads to a lower incidence of ischeamic stroke and death from vascular causes. The project is a sub-study within the 8th wave of the population based Tromsø Study. Information on previous diseases, medication use, and risk factors is collected through questionnaires, blood samples, and measurements of height, weight, blood pressure, and ECG.
A total of 4,000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized to either long-term heart rhythm monitoring (7 days) or a control group without long-term ECG monitoring (2,000 in each group). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.
The intervention group and the control group will be compared with regards to incident stroke and death within a 6-year follow-up period. Information on endpoints and anticoagulation use will be obtained through linkage to national registries.
详细描述
This project has the potential for providing new knowledge related to the benefit of a stepwise screening approach for AF according to NT-proBNP level, utilizing a novel patch monitor with continuous ECG monitoring and automatic artificial intelligence based (AI) ECG analysis. The present project is planned as a sub-study of the epidemiological population-based Tromsø Study. In a randomized controlled clinical trial, we plan to test the primary hypothesis that in individuals with elevated NT-ProBNP who are diagnosed with AF through long-term ECG monitoring, anticoagulation treatment according to international guidelines will reduce the incidence of incident ischeamic stroke and cardiovascular death in the screening group compared to individuals who do not undergo screening (control group). The study will be performed within a well-defined cohort with extensive available longitudinal and cross-sectional information on risk factors and co-existing conditions. This setup facilitates addressing several knowledge gaps concerning risk stratification including associations between AF and echocardiographic parameters, cognitive impairment, structural changes on brain MRI, and HRQoL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥40 years
- •NT-proBNP> median level
- •Informed consent for participation
排除标准
- •History of AF (self-reported)
- •Use of anticoagulation therapy
- •Pacemaker/CRT device
- •No available smart phone
结局指标
主要结局
Number of participants with the composite outcome of ischemic stroke or cardiovascular death
时间窗: Within 6 years of screening
Composite outcome of ischemic stroke and cardiovascular death
Number of participants with ischemic stroke
时间窗: Within 6 years of screening
Ischemic stroke outcome
Number of participants with intracerebral hemorrhage
时间窗: Within 6 years of screening
Intracerebral hemorrhage outcome
Number of participants with cardiovascular death
时间窗: Within 6 years of screening
Cardiovascular death outcome
次要结局
- Number of participants with atrial fibrillation(Within 14 days of screening)
- Duration of atrial fibrillation in hours(Within 14 days of screening)
- Left atrial volume index(Within 1 year of screening)
- Left atrial reservoir strain(Within 1 year of screening)
- Score on the 12-word immediate recall test(Within 6 years of screening)
- Score on the Mini-Mental State Examination (MMS-E)(Within 6 years of screening)
- Score on the digit symbol coding test(Within 6 years of screening)
- Score on the HRQoL EuroQol-5 Dimension (EQ5D)(Within one year of screening)
- Score on the Whiteley Index(Within one year of screening)
- Global brain volume(Within 2.5 years of screening)
- Segmental brain volume(Within 2.5 years of screening)
- Volume of white matter lesions(Within 2.5 years of screening)
- Number of clinical and subclinical infarcts(Within 2.5 years of screening)
- Number og micro-hemorrhages(Within 2.5 years of screening)