Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II (STROKESTOP II)
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|ClinicalTrials.gov Identifier: NCT02743416|
Recruitment Status : Active, not recruiting
First Posted : April 19, 2016
Last Update Posted : November 25, 2020
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Stroke||Other: ECG screening (Zenicor-ECG) for atrial fibrillation|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||6868 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
Will be screened for AF using only one-stop protocol
Other: ECG screening (Zenicor-ECG) for atrial fibrillation
Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
as per regular standard as of today
- Incidence of stroke or systemic embolism in the control group vs the intervention group [ Time Frame: 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). [ Time Frame: Five years ]Endpoints collected from the Swedish patient registry will be compared between the groups
- Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group [ Time Frame: Five years ]Endpoints collected from the Swedish patient registry will be compared between the groups
- Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L. [ Time Frame: Two years ]All individuals with NT-proBNP>125ng/L will undergo intermittent ECG recordings at least twice daily for two weeks.
- 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. [ Time Frame: 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. [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Four years ]Participants are asked if they have had symptoms of palpitations before screening visit
- To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743416
|Karolinska Trial Alliance, KTA Prim|
|Stockholm, Sweden, 11361|
|Principal Investigator:||Mårten Rosenqvist, MD||Karolinska Institutet|