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
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation Stroke||Other: ECG screening (Zenicor-ECG) for atrial fibrillation|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||8000 participants|
|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|
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.
as per regular standard as of today
- Reduced incidence of stroke in low-risk group compared to control group [ Time Frame: Five years ]
- 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 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.
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
|Karolinska Trial Alliance, KTA Prim|
|Stockholm, Sweden, 11361|