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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 : August 9, 2018
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
Professor Mårten Rosenqvist, Karolinska University Hospital

Brief Summary:
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.

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 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


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



Primary Outcome Measures :
  1. Reduced incidence of stroke in low-risk group compared to control group [ Time Frame: Five years ]

Secondary Outcome Measures :
  1. 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.

  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. Biomarkers within coagulation, inflammation and cardiomyocyte stress will be analysed with Proseek® Multiplex CVD II96x96 & Proseek® Multiplex CVD III96x96 immunoassays, in order to identify the best discriminator for silent AF on population level. [ Time Frame: Five years ]

    Proseek Multiplex CVD II96x96 is focused on low-abundance biomarkers and uses 1 µL of undiluted sample to measure 92 markers simultaneously.

    Proseek Multiplex CVD III96x96 is focused on high-abundance biomarkers and uses 1 µL of a 1:100 dilution of each sample to measure 92 markers simultaneously.




Information from the National Library of Medicine

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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

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 Pharma AG

Additional Information:

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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: August 9, 2018
Last Verified: August 2018
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