Atrial Fibrillation Clinical Trial
Official title:
STROKESTOP III - Optimized Method for Atrial Fibrillation Screening
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.
Status | Recruiting |
Enrollment | 2200 |
Est. completion date | June 30, 2026 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years to 76 Years |
Eligibility | Inclusion Criteria: - Individuals aged 75/76 in 2024 (born 1948, 1949) - Must reside in the region of Värmland - Must be listed at a primary care facility Exclusion Criteria: - Treatment with oral anti coagulation treatment (OAC) - Contraindications for OAC treatment - Prior atrial fibrillation - Unable to provide consent |
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet, Dept Med H | Stockholm | |
Sweden | Region Värmland | Värmland |
Lead Sponsor | Collaborator |
---|---|
Danderyd Hospital | Karolinska Institutet, Landstinget i Värmland |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | AF detection in opportunistic compared to systematic screening | Proportion of participants with newly diagnosed AF in the screening groups | 12 months | |
Secondary | OAC treatment after AF detection | Proportion of participants with AF on OAC treatment after AF detection by manual follow up | 12 months | |
Secondary | Compliance to OAC treatment 1 year after initiation | Proportion of participants with AF on OAC treatment after AF detection | 12 months | |
Secondary | Health economy | Health-economic assessment of costs accrued in the systematic screening group compared to the opportunistic screening group | 12 months | |
Secondary | Composite endpoint of stroke, death and severe bleeding | A combined endpoint of the rate of stroke, all-cause death and severe bleeding leading to hospitalization in the group randomized to systematic screening compared to opportunistic screening | 5 years | |
Secondary | Reminder strategy effect on participation | The proportional increase in participation after reminder letter is sent out in both groups. | 12 months | |
Secondary | Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group | Proportion of new AF detected in the group determined as high risk per AI-algorithm compared to the group marked as low risk by the AI algorithm.
An AI-algorithm using a neural network has previously been developed (PMID: 36881777) and will be prospectively tested to determine if individuals classified as high-risk to develop AF by the AI-algorithm on their initial electrocardiogram have an increased risk of screening-detected AF. The ECG reviewers will be blinded to the result of the AI-algorithm. |
12 months | |
Secondary | Application of the FIND-AF algorithm | An artificial intelligence model developed from electronic health care records in the United Kingdom has shown an increased risk of incident atrial fibrillation. We aim to determine how accurate the pre-specified variables from the FIND-AF algorithm (age, gender, presence of valvular disease, chronic pulmonary disease, chronic renal failure, as well as Chads-Vasc parameters) can predict atrial fibrillation (reported by sensitivity, specificity and area under the curve). | 12 months |
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