An interventional study of Long term heart rythm monitoring by ECG247 in Atrial Fibrillation (AF), Stroke and NT-pro-BNP, sponsored by University Hospital of North Norway. Recruiting at 2 sites in Norway. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by University Hospital of North Norway · Not applicable, Interventional, and Screening
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.
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.
Exclusion Criteria:
A total of 2000 individuals with NT-proBNP levels above the median, without previously known atrial fibrillation (AF) or ongoing anticoagulation therapy, will be randomized long-term heart rhythm monitoring using ECG247 (5-7 days). Individuals with AF in the intervention group will be offered anticoagulation therapy in accordance with current guidelines.
Diagnostic Test: Long term heart rythm monitoring by ECG247
The control arm
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 trained algorithms which classify arrhythmias based on current criteria. All ECG recordings will be reviewed by a group of trained and experienced study nurses and physicians. In the event of clinically relevant arrhythmias, participants will be contacted as soon as possible and receive advice on follow-up with their general practitioner. Anticoagulation therapy and other treatments will be recommended if indicated according to current guidelines.
Number of participants with the composite outcome of ischemic stroke or cardiovascular death
Composite outcome of ischemic stroke and cardiovascular death
Time frame: Within 6 years of screening
Number of participants with ischemic stroke
Ischemic stroke outcome
Time frame: Within 6 years of screening
Number of participants with intracerebral hemorrhage
Intracerebral hemorrhage outcome
Time frame: Within 6 years of screening
Number of participants with cardiovascular death
Cardiovascular death outcome
Time frame: Within 6 years of screening
Number of participants with atrial fibrillation
Atrial fibrillation prevalence
Time frame: Within 14 days of screening
Duration of atrial fibrillation in hours
Atrial fibrillation burden
Time frame: Within 14 days of screening
Left atrial volume index
Echocardiographic measure
Time frame: Within 1 year of screening
Left atrial reservoir strain
Echocardiographic measures
Time frame: Within 1 year of screening
Score on the 12-word immediate recall test
Cognitive test performance outcome
Time frame: Within 6 years of screening
Score on the Mini-Mental State Examination (MMS-E)
Cognitive test performance outcome
Time frame: Within 6 years of screening
Score on the digit symbol coding test
Cognitive test performance outcome
Time frame: Within 6 years of screening
Score on the HRQoL EuroQol-5 Dimension (EQ5D)
Health related quality of life (HRQoL) outcome
Time frame: Within one year of screening
Score on the Whiteley Index
Health anxiety outcome
Time frame: Within one year of screening
Global brain volume
Brain MRI measures
Time frame: Within 2.5 years of screening
Segmental brain volume
Brain MRI measures
Time frame: Within 2.5 years of screening
Volume of white matter lesions
Brain MRI measures
Time frame: Within 2.5 years of screening
Number of clinical and subclinical infarcts
Brain MRI measures
Time frame: Within 2.5 years of screening
Number og micro-hemorrhages
Brain MRI measures
Time frame: Within 2.5 years of screening
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University Hospital of North Norway