Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Long term heart rythm monitoring by ECG247.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF), Stroke, NT-pro-BNP, Cognitive Function and Well-Being. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test Long term heart rythm monitoring by ECG247
The AF screening device will be sent by post from the study centre to participants in the intervention group at inclusion, free-of-charge. User guides and a "help-desk" located at the University Hospital of North Norway will be available for phone/video assistance. Continuous ECG monitoring using the Norwegian produced ECG247 sensor will be performed for 5-7 days. Single lead ECG data is sent to a cloudbased server intermittently. The system stores information of ECG quality and is evaluated by
Primary outcome measures
- Number of participants with the composite outcome of ischemic stroke or cardiovascular death [Time frame: Within 6 years of screening]
- Number of participants with ischemic stroke [Time frame: Within 6 years of screening]
- Number of participants with intracerebral hemorrhage [Time frame: Within 6 years of screening]
- Number of participants with cardiovascular death [Time frame: Within 6 years of screening]
Secondary outcome measures (12)
- Number of participants with atrial fibrillation [Time frame: Within 14 days of screening]
- Duration of atrial fibrillation in hours [Time frame: Within 14 days of screening]
- Left atrial volume index [Time frame: Within 1 year of screening]
- Left atrial reservoir strain [Time frame: Within 1 year of screening]
- Score on the 12-word immediate recall test [Time frame: Within 6 years of screening]
- Score on the Mini-Mental State Examination (MMS-E) [Time frame: Within 6 years of screening]
- Score on the digit symbol coding test [Time frame: Within 6 years of screening]
- Score on the HRQoL EuroQol-5 Dimension (EQ5D) [Time frame: Within one year of screening]
- Score on the Whiteley Index [Time frame: Within one year of screening]
- Global brain volume [Time frame: Within 2.5 years of screening]
- Segmental brain volume [Time frame: Within 2.5 years of screening]
- Volume of white matter lesions [Time frame: Within 2.5 years of screening]
Eligibility criteria
Inclusion criteria
- Age ≥40 years
- NT-proBNP> median level
- Informed consent for participation
Exclusion criteria
- History of AF (self-reported)
- Use of anticoagulation therapy
- Pacemaker/CRT device
- No available smart phone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Norway · 2 centers
- Uit The Arctic University of Norway — Tromsø
- University Hospital of North Norway Health Trust — Tromsø
Identifiers
NCT: NCT07343895 · 2025/856478 (REK)