Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02743416
• Other study ID #: STROKESTOP II
• Status: Active, not recruiting
• Start date: April 2016
• Est. completion date: April 2023

Study information

• Verified date: November 2020
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6868
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 76 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Not fulfilling the inclusion criteria

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• ECG screening (Zenicor-ECG) for atrial fibrillation
Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.

Locations

Country	Name	City	State
Sweden	Karolinska Trial Alliance, KTA Prim	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Roche Diagnostics

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of stroke or systemic embolism in the control group vs the intervention group	Endpoints collected from the Swedish patient registry will be compared between the groups	Five years
Primary	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).	Endpoints collected from the Swedish patient registry will be compared between the groups	Five years
Secondary	Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group	Endpoints collected from the Swedish patient registry will be compared between the groups	Five years
Secondary	Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.	All individuals with NT-proBNP>125ng/L will undergo intermittent ECG recordings at least twice daily for two weeks.	Two years
Secondary	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.	Participants and non-participants will be compared using socioeconomic data provided by statistics sweden	Two years
Secondary	Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.	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.	Five years
Secondary	Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)	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/	Five years
Secondary	To assess the incidence of heart failure in patients with NT-proBNP>125ng/L	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.	Five years
Secondary	To study atrial function in patients with and without silent atrial fibrillation	In a subset of participants with and without atrial fibrillation, advanced atrial echocardiography will be performed	Five years
Secondary	To study the correlation between symptoms and newly discovered AF	Participants are asked if they have had symptoms of palpitations before screening visit	Four years
Secondary	To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG	pulse palpation will be performed in all participants and then a single-lead ECG will be registered	Four years
Secondary	To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF	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.	Two years
Secondary	To compare different ECG modalities for AF screening	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.	Two years
Secondary	Incidence of undiagnosed hypertension in participants	Blood pressure will be measured and participants with elevated blood pressure but no previous diagnosis of hypertension will be referred for further evaluation	four years