Population-based Atrial Fibrillation Screening in Individuals With NT-proBNP Above Median in the Tromsø Study

Официальное название

Atrial Fibrillation and Long Term ECG Monitoring of Heart Rhythm in the Tromsø Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Number of participants with the composite outcome of ischemic stroke or cardiovascular death [Срок оценки: Within 6 years of screening]
• Number of participants with ischemic stroke [Срок оценки: Within 6 years of screening]
• Number of participants with intracerebral hemorrhage [Срок оценки: Within 6 years of screening]
• Number of participants with cardiovascular death [Срок оценки: Within 6 years of screening]

Вторичные конечные точки (12)

• Number of participants with atrial fibrillation [Срок оценки: Within 14 days of screening]
• Duration of atrial fibrillation in hours [Срок оценки: Within 14 days of screening]
• Left atrial volume index [Срок оценки: Within 1 year of screening]
• Left atrial reservoir strain [Срок оценки: Within 1 year of screening]
• Score on the 12-word immediate recall test [Срок оценки: Within 6 years of screening]
• Score on the Mini-Mental State Examination (MMS-E) [Срок оценки: Within 6 years of screening]
• Score on the digit symbol coding test [Срок оценки: Within 6 years of screening]
• Score on the HRQoL EuroQol-5 Dimension (EQ5D) [Срок оценки: Within one year of screening]
• Score on the Whiteley Index [Срок оценки: Within one year of screening]
• Global brain volume [Срок оценки: Within 2.5 years of screening]
• Segmental brain volume [Срок оценки: Within 2.5 years of screening]
• Volume of white matter lesions [Срок оценки: Within 2.5 years of screening]

Критерии участия

Критерии включения

• Age ≥40 years
• NT-proBNP> median level
• Informed consent for participation

Критерии исключения

• History of AF (self-reported)
• Use of anticoagulation therapy
• Pacemaker/CRT device
• No available smart phone

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Норвегия · 2 центра

• Uit The Arctic University of Norway — Tromsø
• University Hospital of North Norway Health Trust — Tromsø

Идентификаторы

NCT: NCT07343895 · 2025/856478 (REK)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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