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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
Sponsor:
Collaborator:
Roche Diagnostics
Information provided by (Responsible Party):
Professor Mårten Rosenqvist, Karolinska University Hospital

Tracking Information
First Submitted Date March 16, 2016
First Posted Date April 19, 2016
Last Update Posted Date November 25, 2020
Study Start Date April 2016
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 20, 2020)
  • 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
Original Primary Outcome Measures
 (submitted: April 14, 2016)
Reduced incidence of stroke in low-risk group compared to control group [ Time Frame: Five years ]
Change History
Current Secondary Outcome Measures
 (submitted: November 20, 2020)
  • 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
Original Secondary Outcome Measures
 (submitted: April 14, 2016)
  • 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.
  • 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.
  • Biomarkers within coagulation, inflammation and cardiomyocyte stress will be analysed in order to identify the best discriminator for silent AF on population level. [ Time Frame: Five years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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 Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
venous blood samples
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).

Condition
  • 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.
Study Groups/Cohorts
  • ECG screening
    Will be screened for AF using only one-stop protocol
    Intervention: Other: ECG screening (Zenicor-ECG) for atrial fibrillation
  • Control group
    as per regular standard as of today
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: November 20, 2020)
6868
Original Estimated Enrollment
 (submitted: April 14, 2016)
8000
Estimated Study Completion Date April 2023
Estimated Primary Completion Date April 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fulfilling the inclusion criteria
Sex/Gender
Sexes Eligible for Study: All
Ages 75 Years to 76 Years   (Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02743416
Other Study ID Numbers STROKESTOP II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Professor Mårten Rosenqvist, Karolinska University Hospital
Study Sponsor Karolinska University Hospital
Collaborators Roche Diagnostics
Investigators
Principal Investigator: Mårten Rosenqvist, MD Karolinska Institutet
PRS Account Karolinska University Hospital
Verification Date November 2020