STROKESTOP III - Optimized Method for Atrial Fibrillation Screening

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75-76
SponsorDanderyd Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Individuals aged 75/76 in 2024 (born 1948, 1949)

Must reside in the region of Värmland

Must be listed at a primary care facility

Disqualifiers

Treatment with oral anti coagulation treatment (OAC)

Contraindications for OAC treatment

Prior atrial fibrillation

Unable to provide consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Screening invitation mode

    Behavioral

    Cluster randomized study to compare mode of invitation

Treatment groups

2,200 Participants
are divided into 2 treatment groups
Group A: Systematic screening groupOther 1 intervention
Group B: Opportunistic screening groupOther 1 intervention

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

AF detection in opportunistic compared to systematic screening

Proportion of participants with newly diagnosed AF in the screening groups

Time frame
12 months
2

OAC treatment after AF detection

Proportion of participants with AF on OAC treatment after AF detection by manual follow up

Time frame
12 months
3

Compliance to OAC treatment 1 year after initiation

Proportion of participants with AF on OAC treatment after AF detection

Time frame
12 months
4

Health economy

Health-economic assessment of costs accrued in the systematic screening group compared to the opportunistic screening group

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Danderyd Hospital

Lead sponsor

Karolinska Institutet

Collaborator

Landstinget i Värmland

Collaborator