Atrial Fibrillation, Stroke
Conditions
Keywords
Screening, Stroke prevention, Cost effectiveness
Brief summary
STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.
Interventions
OTHERECG screening (Zenicor-ECG) for atrial fibrillation
Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
Sponsors
Roche Diagnostics GmbH
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
75 Years to 76 Years
Healthy volunteers
Yes
Inclusion criteria
* Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion
Exclusion criteria
* Not fulfilling the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of stroke or systemic embolism in the control group vs the intervention group | Five years | Endpoints collected from the Swedish patient registry will be compared between the groups |
| Incidence of stroke or systemic embolism in the control group vs the low-risk group (with NT-proBNP<125 ng/L and normal index 1-lead ECG). | Five years | Endpoints collected from the Swedish patient registry will be compared between the groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To assess screening uptake with regards to socio-demographic factors and to study if we can improve uptake in the screening programme by decentralizing the recruitment procedure. | Two years | Participants and non-participants will be compared using socioeconomic data provided by statistics sweden |
| Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program. | Five years | With the same statistical methods used in STROKESTOP I, the number of fewer years with undetected AF will be calculated as well as the number of avoided strokes, the number of life-years and the number of quality-adjusted life years (QALYs) per 1000 screened patients. The result will be reported as the incremental cost per gained QALY and per avoided stroke. |
| Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF) | Five years | serum and plasma biomarkers within coagulation, inflammation, cardiomyocyte stress, atrial fibrosis, electrical remodelling, prothrombotic state and altered haemodynamics will be analysed with immunoassays, in order to identify the best discriminator for silent AF on population level. https://www.olink.com/products/cvd-iii-panel/ |
| To assess the incidence of heart failure in patients with NT-proBNP>125ng/L | Five years | To assess the value of structured follow-up with echocardiography in participants without known heart failure, but with increased NT-proBNP as a method to diagnose heart failure with reduced and preserved ejection fraction; and to assess whether in patients with NT-proBNP \> 125 pg/mL, a higher cut-off can be used to predict HF on echocardiography, and thus be used to triage asymptomatic patients to echocardiography. |
| To study atrial function in patients with and without silent atrial fibrillation | Five years | In a subset of participants with and without atrial fibrillation, advanced atrial echocardiography will be performed |
| Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group | Five years | Endpoints collected from the Swedish patient registry will be compared between the groups |
| To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG | Four years | pulse palpation will be performed in all participants and then a single-lead ECG will be registered |
| To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF | Two years | Individuals with micro-AF, defined as at least five supraventricular ectopics in a row but lasting shorter than 30 seconds at any time during intermittent screening will be compared to participants without micro-AF with regard to incident AF during screening. |
| To compare different ECG modalities for AF screening | Two years | A subset of participants will perform both single-lead, handheld, intermittent ECG (Zenicor) and continuous event loop ECG recordings (Novacor R-test 4) and AF yield (defined as at least one episode of AF with a duration of 30 seconds) will be compared between the methods. Tolerability to both methods will be measured qualitatively with a questionnaire. |
| Incidence of undiagnosed hypertension in participants | four years | Blood pressure will be measured and participants with elevated blood pressure but no previous diagnosis of hypertension will be referred for further evaluation |
| To study the correlation between symptoms and newly discovered AF | Four years | Participants are asked if they have had symptoms of palpitations before screening visit |
| Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L. | Two years | All individuals with NT-proBNP\>125ng/L will undergo intermittent ECG recordings at least twice daily for two weeks. |
Countries
Sweden
Outcome results
None listed