Clinical trial NCT02743416: Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Stroke
Keywords: Screening
Stroke prevention
Cost effectiveness
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2016-04-19
Enrollment: 6868
Sex: ALL
Minimum age (years): 75
Maximum age (years): 76
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals aged 75/76 residing in Stockholm will be identified using their 10-digit personal identification number. All identified subjects will be randomized in a 1:1 fashion to be invited to screening for AF or to serve as a control group.

Participants with a prior diagnosis of AF will be asked if they are on treatment with anticoagulants. If they are not, a referral to cardiologist will be made to ensure appropriate treatment.

Individuals without known AF will have blood samples drawn and analysed with regard to NT-proBNP using point of care analysis.

All individuals with NT-proBNP\> 125 ng/L and without known AF will be taught to undergo intermittent ECG recordings twice daily for two weeks (High-risk Group). Individuals with a NT-proBNP\<125 ng/L will do one initial 1-lead ECG, and if normal not undergo further ECG screening (low-risk Group).

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.


Eligibility criteria: Inclusion Criteria:

* Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion

Exclusion Criteria:

* Not fulfilling the inclusion criteria

Primary outcomes:
measure: Incidence of stroke or systemic embolism in the control group vs the intervention group
timeFrame: Five years
measure: 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).
timeFrame: Five years
Secondary outcomes:
measure: Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group
timeFrame: Five years
measure: Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.
timeFrame: Two years
measure: 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.
timeFrame: Two years
measure: Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.
timeFrame: Five years
measure: Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)
timeFrame: Five years
measure: To assess the incidence of heart failure in patients with NT-proBNP>125ng/L
timeFrame: Five years
measure: To study atrial function in patients with and without silent atrial fibrillation
timeFrame: Five years
measure: To study the correlation between symptoms and newly discovered AF
timeFrame: Four years
measure: To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG
timeFrame: Four years
measure: To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF
timeFrame: Two years
measure: To compare different ECG modalities for AF screening
timeFrame: Two years
measure: Incidence of undiagnosed hypertension in participants
timeFrame: four years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance, KTA Prim
Study officials:
affiliation: Karolinska Institutet
name: Mårten Rosenqvist, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fredriksson T, Gudmundsdottir KK, Frykman V, Friberg L, Al-Khalili F, Engdahl J, Svennberg E. Brief episodes of rapid irregular atrial activity (micro-AF) are a risk marker for atrial fibrillation: a prospective cohort study. BMC Cardiovasc Disord. 2020 Apr 10;20(1):167. doi: 10.1186/s12872-020-01453-w.