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| Name | Class |
|---|---|
| UiT The Arctic University of Norway | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Experimental | 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. |
|
| Control | No Intervention | The control arm |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long term heart rythm monitoring by ECG247 | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with the composite outcome of ischemic stroke or cardiovascular death | Composite outcome of ischemic stroke and cardiovascular death | Within 6 years of screening |
| Number of participants with ischemic stroke | Ischemic stroke outcome | Within 6 years of screening |
| Number of participants with intracerebral hemorrhage | Intracerebral hemorrhage outcome | Within 6 years of screening |
| Number of participants with cardiovascular death | Cardiovascular death outcome | Within 6 years of screening |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with atrial fibrillation | Atrial fibrillation prevalence | Within 14 days of screening |
| Duration of atrial fibrillation in hours | Atrial fibrillation burden |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Agnethe Eltoft, MD, PhD | Contact | +4797193417 | agnethe.eltoft@unn.no | |
| Emelia Gjesvik | Contact | emelia.e.gjesvik@uit.no |
| Name | Affiliation | Role |
|---|---|---|
| Tor Ingenbrigtsen | University Hospital of North Norway | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uit The Arctic University of Norway | Recruiting | Tromsø | 1902 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 18, 2025 | Jul 18, 2025 |
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In the planned open label randomized screening trial trial we plan to include 4000 individuals fra the 8th wave of the population based Tromsø Study with NT-proBNP above median without previous known AF or ongoing anticoagulant treatment. Participants will be randomized 1:1 to continuous ECG monitoring using the Norwegian produced ECG247 sensor. og to the control group without any monitoring of heart rythm.
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|
| Within 14 days of screening |
| Left atrial volume index | Echocardiographic measure | Within 1 year of screening |
| Left atrial reservoir strain | Echocardiographic measures | Within 1 year of screening |
| Score on the 12-word immediate recall test | Cognitive test performance outcome | Within 6 years of screening |
| Score on the Mini-Mental State Examination (MMS-E) | Cognitive test performance outcome | Within 6 years of screening |
| Score on the digit symbol coding test | Cognitive test performance outcome | Within 6 years of screening |
| Score on the HRQoL EuroQol-5 Dimension (EQ5D) | Health related quality of life (HRQoL) outcome | Within one year of screening |
| Score on the Whiteley Index | Health anxiety outcome | Within one year of screening |
| Global brain volume | Brain MRI measures | Within 2.5 years of screening |
| Segmental brain volume | Brain MRI measures | Within 2.5 years of screening |
| Volume of white matter lesions | Brain MRI measures | Within 2.5 years of screening |
| Number of clinical and subclinical infarcts | Brain MRI measures | Within 2.5 years of screening |
| Number og micro-hemorrhages | Brain MRI measures | Within 2.5 years of screening |
| University Hospital of North Norway Health Trust | Recruiting | Tromsø | Norway |
|
| Prot_000.pdf |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| D006333 | Heart Failure |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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