protocolSection identificationModule nctId: NCT06275503, orgStudyIdInfo id: STROKESTOP III, briefTitle: STROKESTOP III - Optimized Method for Atrial Fibrillation Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2026-06-30, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Danderyd Hospital, class: OTHER, collaborators name: Karolinska Institutet, collaborators name: Landstinget i Värmland, descriptionModule briefSummary: Atrial fibrillation is the most common sustained cardiac arrhythmia affecting more than 3% of the adult population. The symptoms of atrial fibrillation can range from asymptomatic to debilitating. It can be permanent in its nature, but also paroxysmal with only short bursts of atrial fibrillation randomly occurring and can therefore remain unnoticed. Atrial fibrillation increases the risk of stroke five fold if left untreated.Screening for atrial fibrillation in elderly populations above age 65 years can result in detection of new atrial fibrillation cases ranging from 0,5% new AF with a single time-point ECG, up to 30% AF if an implantable loop recorder is inserted for 3 years.Currently opportunistic screening using pulse palpation, or a single time-point ECG is recommended by the European Society of Cardiology guidelines. Systematic screening in individuals aged 75 or above, or at a high stroke risk should be considered.Overall, participation in systematic atrial fibrillation screening trials has been shown to be relatively low with almost 50% non-participants. Participants are generally healthier, with higher socioeconomic status, hence the ones who would potentially benefit the most remain absent.Opportunistic screening has shown promising results with higher participation rates and the possibility of better outreach. There is a lack of data from randomized trials on the difference in participation rates in systematic and opportunistic screening approaches when screening with prolonged ECG monitoring., conditionsModule conditions: Atrial Fibrillation, conditions: Atrial Fibrillation New Onset, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Cluster randomized trial, primaryPurpose: SCREENING, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 2200, type: ESTIMATED, armsInterventionsModule interventions name: Screening invitation mode, outcomesModule primaryOutcomes measure: Participation in screening, secondaryOutcomes measure: AF detection in opportunistic compared to systematic screening, secondaryOutcomes measure: OAC treatment after AF detection, secondaryOutcomes measure: Compliance to OAC treatment 1 year after initiation, secondaryOutcomes measure: Health economy, secondaryOutcomes measure: Composite endpoint of stroke, death and severe bleeding, secondaryOutcomes measure: Reminder strategy effect on participation, secondaryOutcomes measure: Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group, secondaryOutcomes measure: Application of the FIND-AF algorithm, eligibilityModule sex: ALL, minimumAge: 75 Years, maximumAge: 76 Years, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Karolinska Institutet, Dept Med H, city: Stockholm, zip: 141 86, country: Sweden, contacts name: Emma Svennberg, MD PhD, role: CONTACT, phone: +46739584822, email: emma.svennberg@regionstockholm.se, contacts name: MD PhD, role: CONTACT, geoPoint lat: 59.33258, lon: 18.0649, locations facility: Region Värmland, city: Värmland, country: Sweden, contacts name: Fredrik Carlstedt, role: CONTACT, geoPoint lat: 60.83333, lon: 16.5, hasResults: False