Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II
- Conditions
- Atrial FibrillationStroke
- Interventions
- Other: ECG screening (Zenicor-ECG) for atrial fibrillation
- Registration Number
- NCT02743416
- Lead Sponsor
- Karolinska University Hospital
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 6868
- Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion
- Not fulfilling the inclusion criteria
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description ECG screening ECG screening (Zenicor-ECG) for atrial fibrillation Will be screened for AF using only one-stop protocol
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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
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.
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
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 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 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
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
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
Trial Locations
- Locations (1)
Karolinska Trial Alliance, KTA Prim
🇸🇪Stockholm, Sweden