STROKESTOP III - Optimized Method for Atrial Fibrillation Screening

NCT06275503 | Recruiting

• 1 other identifier: STROKESTOP III
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Fibrillation; Atrial Fibrillation New Onset

Outcome Measures

Primary Outcomes (1)

• Participation in screening

  Proportion of invitees participating in screening in each screening arm. The primary hypothesis is that opportunistic screening will increase participation by 25 % compared to systematic screening

  12 months

Secondary Outcomes (8)

• AF detection in opportunistic compared to systematic screening

  12 months

• OAC treatment after AF detection

  12 months

• Compliance to OAC treatment 1 year after initiation

  12 months

• Health economy

  12 months

• Composite endpoint of stroke, death and severe bleeding

  5 years

Study Arms (2)

Systematic screening group

OTHER

Individuals aged 75/76 randomized to systematic screening are invited through a centralized screening facility to participate in prolonged ECG screening.

Behavioral: Screening invitation mode

Opportunistic screening group

OTHER

Individuals aged 75/76 randomized to opportunistic screening are invited to participate when they visit their primary care facility to prolonged ECG screening.

Behavioral: Screening invitation mode

Interventions

Screening invitation mode BEHAVIORAL

Cluster randomized study to compare mode of invitation

Opportunistic screening group; Systematic screening group

Eligibility Criteria

• Age: 75 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals aged 75/76 in 2024 (born 1948, 1949)
• Must reside in the region of Värmland
• Must be listed at a primary care facility

You may not qualify if:

• Treatment with oral anti coagulation treatment (OAC)
• Contraindications for OAC treatment
• Prior atrial fibrillation
• Unable to provide consent

Sponsors & Collaborators

• Danderyd Hospital: lead
• Karolinska Institutet: collaborator
• Landstinget i Värmland: collaborator

Study Sites (2)

Karolinska Institutet, Dept Med H

Stockholm, 141 86, Sweden

NOT YET RECRUITING

Region Värmland

Värmland, Sweden

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Emma Svennberg, MD PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Svennberg, MD PhD

CONTACT

+46739584822; emma.svennberg@regionstockholm.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized trial

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: February 23, 2024
• Study Start: May 2, 2024
• Primary Completion: February 28, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)