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

Recruiting

Phase N/A Results N/A

Trial Description

The STROKESTOP II study is a proposed study to determine 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.

Conditions

Interventions

  • ECG screening for atrial fibrillation Other
    Intervention Desc: Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
    ARM 1: Kind: Experimental
    Label: ECG screening
    Description: Will be screened for AF using only one-stop protocol
  • ECG screening (Zenicor-ECG) for atrial fibrillation Other
    Intervention Desc: Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
    ARM 1: Kind: Experimental
    Label: ECG screening
    Description: Will be screened for AF using only one-stop protocol

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial 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).

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduced incidence of stroke in low-risk group compared to control group Five years Yes
Secondary Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program. Five years No
Secondary Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L. Two years Yes
Secondary Biomarkers within coagulation, inflammation and cardiomyocyte stress will be analysed in order to identify the best discriminator for silent AF on population level. Five years Yes
Secondary Biomarkers within coagulation, inflammation and cardiomyocyte stress will be analysed with ProseekĀ® Multiplex CVD II96x96 & ProseekĀ® Multiplex CVD III96x96 immunoassays, in order to identify the best discriminator for silent AF on population level. Five years Yes

Sponsors