Atrial FibrillationNCT06275503
STROKESTOP III - Optimized Method for Atrial Fibrillation Screening
A study testing Screening invitation mode in people with Atrial Fibrillation and Atrial Fibrillation New Onset, run by Danderyd Hospital at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 76 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation New Onset
- What is being tested?
- Screening invitation mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 2 sitesSweden
- Study dates
- 2 May 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 76 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Individuals aged 75/76 in 2024 (born 1948, 1949)
- Must reside in the region of Värmland
- Must be listed at a primary care facility
Who cannot join
- Treatment with oral anti coagulation treatment (OAC)
- Contraindications for OAC treatment
- Prior atrial fibrillation
- Unable to provide consent
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites, 2 recruiting
- Not yet recruiting
Karolinska Institutet, Dept Med H
Stockholm, 141 86
Emma Svennberg, MD PhD, +46739584822, emma.svennberg@regionstockholm.se
MD PhD
- Recruiting
Region Värmland
Värmland
Fredrik Carlstedt
About this study
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.
Read more
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.
Read the detailed description
Plans and methods; Primary care facilities in the region of Värmland with at least 200 75-76 year-old listed will be randomized to either:
- Systematic screening. All 75/76 year old belonging to a primary care facility randomized to systematic screening will receive a letter with an invitation to screening through the Clinical Physiology department at Karlstad Central Hospital.
- Opportunistic screening. All 75/76 year old attending their primary care facility for any health related reason will be invited to screening at the primary care facility.
A complete list of all listed individuals will be drawn from each primary care facility list of patients for both screening arms at the beginning of the study.
Inclusion criteria: All individuals aged 75/76 residing in the region of Värmland, listed at a primary care facility with > 200 individuals aged 75/76 Exclusion criteria: Individuals with ongoing oral anti coagulation treatment (OAC), contraindication for OAC treatment and/or known and treated atrial fibrillation will be excluded from participation. Individuals not being able to consent will be excluded from participation.
All participants will be asked to fill out a health declaration. A hand-held single-lead ECG (Zenicor One) will be sent to the participant via mail. The device will be used to measure ECGs on a regular basis three times a day, and during symptoms. ECGs are transferred for interpretation through the mobile network. All ECGs will be manually interpreted by specifically trained physiologists.
All positive findings are communicated to primary care by the physiologists for initiation of OAC treatment. All negative findings are communicated to the participant via mail.
Participation status, and new AF diagnosis will be assessed immediately after study closure. Secondary endpoints will be assessed at one year through Swedish national patients' registries.
In a sub-study an artificial intelligence model will be scoring all individuals' risk of developing AF based on the initial ECG (unless there is substantial noise, then second ECG will be used). The AI analysis will be blinded to the interpreter of the ECGs. All participants will be stratified into a low-risk and a high-risk group of developing AF during screening based on the AI analysis. At the end of the screening period the outcome of the AI model will be compared with the results of the screening.
In a sub study the investigators will use artificial intelligence as a means of assessment support when interpreting ECGs. The artificial intelligence model has been used to determine a cut-off for high and low risk individuals and will be prospectively evaluated to determine if it can be used to identify individuals that will benefit most from AF screening.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation New Onset
- Being tested
- Screening invitation mode
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening invitation modeBehavioural
Cluster randomized study to compare mode of invitation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Screening invitation mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Secondary outcomes (8)
AF detection in opportunistic compared to systematic screening
Proportion of participants with newly diagnosed AF in the screening groups
Measured: 12 months
OAC treatment after AF detection
Proportion of participants with AF on OAC treatment after AF detection by manual follow up
Measured: 12 months
Compliance to OAC treatment 1 year after initiation
Proportion of participants with AF on OAC treatment after AF detection
Measured: 12 months
Health economy
Health-economic assessment of costs accrued in the systematic screening group compared to the opportunistic screening group
Measured: 12 months
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
Measured: 5 years
Reminder strategy effect on participation
The proportional increase in participation after reminder letter is sent out in both groups.
Measured: 12 months
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.
Measured: 12 months
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start2 May 2024
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Landstinget i Värmland
- Responsible party
- Sponsor
- Investigators
- Emma Svennberg, MD PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06275503
- Sponsor's protocol ID
- STROKESTOP III
- Status last verified
- May 2024
- First submitted
- 6 Nov 2023
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STROKESTOP III - Optimized Method for Atrial Fibrillation Screening
- ClinicalTrials.gov ID
- NCT06275503
- Acronym / sponsor ID
- STROKESTOP III
- Conditions
- Atrial Fibrillation, Atrial Fibrillation New Onset
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Landstinget i Värmland
- Study start
- 2 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Plans and methods; Primary care facilities in the region of Värmland with at least 200 75-76 year-old listed will be randomized to either:
- Systematic screening. All 75/76 year old belonging to a primary care facility randomized to systematic screening will receive a letter with an invitation to screening through the Clinical Physiology department at Karlstad Central Hospital.
- Opportunistic screening. All 75/76 year old attending their primary care facility for any health related reason will be invited to screening at the primary care facility.
A complete list of all listed individuals will be drawn from each primary care facility list of patients for both screening arms at the beginning of the study.
Inclusion criteria: All individuals aged 75/76 residing in the region of Värmland, listed at a primary care facility with > 200 individuals aged 75/76 Exclusion criteria: Individuals with ongoing oral anti coagulation treatment (OAC), contraindication for OAC treatment and/or known and treated atrial fibrillation will be excluded from participation. Individuals not being able to consent will be excluded from participation.
All participants will be asked to fill out a health declaration. A hand-held single-lead ECG (Zenicor One) will be sent to the participant via mail. The device will be used to measure ECGs on a regular basis three times a day, and during symptoms. ECGs are transferred for interpretation through the mobile network. All ECGs will be manually interpreted by specifically trained physiologists.
All positive findings are communicated to primary care by the physiologists for initiation of OAC treatment. All negative findings are communicated to the participant via mail.
Participation status, and new AF diagnosis will be assessed immediately after study closure. Secondary endpoints will be assessed at one year through Swedish national patients' registries.
In a sub-study an artificial intelligence model will be scoring all individuals' risk of developing AF based on the initial ECG (unless there is substantial noise, then second ECG will be used). The AI analysis will be blinded to the interpreter of the ECGs. All participants will be stratified into a low-risk and a high-risk group of developing AF during screening based on the AI analysis. At the end of the screening period the outcome of the AI model will be compared with the results of the screening.
In a sub study the investigators will use artificial intelligence as a means of assessment support when interpreting ECGs. The artificial intelligence model has been used to determine a cut-off for high and low risk individuals and will be prospectively evaluated to determine if it can be used to identify individuals that will benefit most from AF screening.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized trial
| Arm | Type | Receives |
|---|---|---|
| Systematic screening group | Other | Behavioral: Screening invitation modeIndividuals aged 75/76 randomized to systematic screening are invited through a centralized screening facility to participate in prolonged ECG screening. |
| Opportunistic screening group | Other | Behavioral: Screening invitation modeIndividuals aged 75/76 randomized to opportunistic screening are invited to participate when they visit their primary care facility to prolonged ECG screening. |
Who may qualify
- Ages
- 75 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Individuals aged 75/76 in 2024 (born 1948, 1949)
- Must reside in the region of Värmland
- Must be listed at a primary care facility
Key exclusion criteria (4 listed)
- Treatment with oral anti coagulation treatment (OAC)
- Contraindications for OAC treatment
- Prior atrial fibrillation
- Unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Screening invitation modeCluster randomized study to compare mode of invitation | Behavioural | Opportunistic screening group, Systematic screening group |
Primary outcome
Participation in screening
Time frame: 12 months
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
8 secondary outcomes
AF detection in opportunistic compared to systematic screening
Time frame: 12 months
OAC treatment after AF detection
Time frame: 12 months
Compliance to OAC treatment 1 year after initiation
Time frame: 12 months
Health economy
Time frame: 12 months
Composite endpoint of stroke, death and severe bleeding
Time frame: 5 years
Reminder strategy effect on participation
Time frame: 12 months
Comparison of automatic ECG analysis (using AI) for detection of AF in a (by AI algorithm classified) high- compared to a low-risk group
Time frame: 12 months
Application of the FIND-AF algorithm
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emma Svennberg, MD PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening invitation mode in people with Atrial Fibrillation and Atrial Fibrillation New Onset, run by Danderyd Hospital at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emma Svennberg, MD PhD (+46739584822, emma.svennberg@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in screening (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2024.