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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

Study Description
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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.

Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Other: ECG screening (Zenicor-ECG) for atrial fibrillation

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 6868 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
ECG screening
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.
Control group
as per regular standard as of today


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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/

  6. 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.

  7. 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

  8. 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

  9. 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

  10. 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.

  11. 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.

  12. 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
venous blood samples

Eligibility Criteria
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Ages Eligible for Study:   75 Years to 76 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Not fulfilling the inclusion criteria
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02743416


Locations
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Sweden
Karolinska Trial Alliance, KTA Prim
Stockholm, Sweden, 11361
Sponsors and Collaborators
Karolinska University Hospital
Roche Diagnostics
Investigators
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Principal Investigator: Mårten Rosenqvist, MD Karolinska Institutet
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Professor Mårten Rosenqvist, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02743416    
Other Study ID Numbers: STROKESTOP II
First Posted: April 19, 2016    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Professor Mårten Rosenqvist, Karolinska University Hospital:
Screening
Stroke prevention
Cost effectiveness
Additional relevant MeSH terms:
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Atrial Fibrillation
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Pathologic Processes