Atrial FibrillationSTROKESTOP IINCT02743416
Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II
An observational study of Atrial Fibrillation and Stroke, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study. Read more about this study
- Who is it for?
- Ages 75 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- ECG screening (Zenicor-ECG) for atrial fibrillation
- How many people
- 6,868 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2016to Apr 2023
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Older adult
Study population: Individuals aged 75/76 residing in Stockholm will be identified using their 10-digit personal identification number. All identified subjects will be randomized in a 1:1 fashion to be invited to screening for AF or to serve as a control group. Participants with a prior diagnosis of AF will be asked if they are on treatment with anticoagulants. If they are not, a referral to cardiologist will be made to ensure appropriate treatment. Individuals without known AF will have blood samples drawn and analysed with regard to NT-proBNP using point of care analysis. All individuals with NT-proBNP> 125 ng/L and without known AF will be taught to undergo intermittent ECG recordings twice daily for two weeks (High-risk Group). Individuals with a NT-proBNP<125 ng/L will do one initial 1-lead ECG, and if normal not undergo further ECG screening (low-risk Group).
Who may be able to join
- Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion
Who cannot join
- Not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- ECG screening (Zenicor-ECG) for atrial fibrillation
- Keywords
- Screening, Stroke prevention, Cost effectiveness
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG screening (Zenicor-ECG) for atrial fibrillationOther
Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| ECG screening | Will be screened for AF using only one-stop protocol Receives: Other: ECG screening (Zenicor-ECG) for atrial fibrillation | |
| Control group | as per regular standard as of today |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of stroke or systemic embolism in the control group vs the intervention group
Endpoints collected from the Swedish patient registry will be compared between the groups
Measured: Five years
Incidence of stroke or systemic embolism in the control group vs the low-risk group (with NT-proBNP<125 ng/L and normal index 1-lead ECG).
Endpoints collected from the Swedish patient registry will be compared between the groups
Measured: Five years
Secondary outcomes (12)
Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group
Endpoints collected from the Swedish patient registry will be compared between the groups
Measured: Five years
Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.
All individuals with NT-proBNP>125ng/L will undergo intermittent ECG recordings at least twice daily for two weeks.
Measured: Two years
To assess screening uptake with regards to socio-demographic factors and to study if we can improve uptake in the screening programme by decentralizing the recruitment procedure.
Participants and non-participants will be compared using socioeconomic data provided by statistics sweden
Measured: Two years
Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.
With the same statistical methods used in STROKESTOP I, the number of fewer years with undetected AF will be calculated as well as the number of avoided strokes, the number of life-years and the number of quality-adjusted life years (QALYs) per 1000 screened patients. The result will be reported as the incremental cost per gained QALY and per avoided stroke.
Measured: Five years
Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)
serum and plasma biomarkers within coagulation, inflammation, cardiomyocyte stress, atrial fibrosis, electrical remodelling, prothrombotic state and altered haemodynamics will be analysed with immunoassays, in order to identify the best discriminator for silent AF on population level. https://www.olink.com/products/cvd-iii-panel/
Measured: Five years
To assess the incidence of heart failure in patients with NT-proBNP>125ng/L
To assess the value of structured follow-up with echocardiography in participants without known heart failure, but with increased NT-proBNP as a method to diagnose heart failure with reduced and preserved ejection fraction; and to assess whether in patients with NT-proBNP > 125 pg/mL, a higher cut-off can be used to predict HF on echocardiography, and thus be used to triage asymptomatic patients to echocardiography.
Measured: Five years
To study atrial function in patients with and without silent atrial fibrillation
In a subset of participants with and without atrial fibrillation, advanced atrial echocardiography will be performed
Measured: Five years
To study the correlation between symptoms and newly discovered AF
Participants are asked if they have had symptoms of palpitations before screening visit
Measured: Four years
To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG
pulse palpation will be performed in all participants and then a single-lead ECG will be registered
Measured: Four years
To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF
Individuals with micro-AF, defined as at least five supraventricular ectopics in a row but lasting shorter than 30 seconds at any time during intermittent screening will be compared to participants without micro-AF with regard to incident AF during screening.
Measured: Two years
To compare different ECG modalities for AF screening
A subset of participants will perform both single-lead, handheld, intermittent ECG (Zenicor) and continuous event loop ECG recordings (Novacor R-test 4) and AF yield (defined as at least one episode of AF with a duration of 30 seconds) will be compared between the methods. Tolerability to both methods will be measured qualitatively with a questionnaire.
Measured: Two years
Incidence of undiagnosed hypertension in participants
Blood pressure will be measured and participants with elevated blood pressure but no previous diagnosis of hypertension will be referred for further evaluation
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6,868 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Responsible party
- Principal investigator, Professor Mårten Rosenqvist, Karolinska University Hospital
- Investigators
- Mårten Rosenqvist, MD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02743416
- Sponsor's protocol ID
- STROKESTOP II
- Acronym
- STROKESTOP II
- Status last verified
- Nov 2020
- First submitted
- 16 Mar 2016
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.
PubMed 39217615Fredriksson T, Gudmundsdottir KK, Frykman V, Friberg L, Al-Khalili F, Engdahl J, Svennberg E. Brief episodes of rapid irregular atrial activity (micro-AF) are a risk marker for atrial fibrillation: a prospective cohort study. BMC Cardiovasc Disord. 2020 Apr 10;20(1):167. doi: 10.1186/s12872-020-01453-w.
PubMed 32276611
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II
- ClinicalTrials.gov ID
- NCT02743416
- Acronym / sponsor ID
- STROKESTOP II / STROKESTOP II
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Screening, Stroke prevention, Cost effectiveness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,868 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH
- Study start
- Apr 2016
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 19 Apr 2016 (estimated)
- 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.
STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG screening | – | Other: ECG screening (Zenicor-ECG) for atrial fibrillationWill be screened for AF using only one-stop protocol |
| Control group | – | –as per regular standard as of today |
Who may qualify
- Ages
- 75 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Individuals aged 75/76 residing in Stockholm will be identified using their 10-digit personal identification number. All identified subjects will be randomized in a 1:1 fashion to be invited to screening for AF or to serve as a control group. Participants with a prior diagnosis of AF will be asked if they are on treatment with anticoagulants. If they are not, a referral to cardiologist will be made to ensure appropriate treatment. Individuals without known AF will have blood samples drawn and analysed with regard to NT-proBNP using point of care analysis. All individuals with NT-proBNP> 125 ng/L and without known AF will be taught to undergo intermittent ECG recordings twice daily for two weeks (High-risk Group). Individuals with a NT-proBNP<125 ng/L will do one initial 1-lead ECG, and if normal not undergo further ECG screening (low-risk Group).
Key inclusion criteria (1 listed)
- Individuals born 1940 and 1941 residing in Stockholm at the time of inclusion
Key exclusion criteria (1 listed)
- Not fulfilling the inclusion criteria
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 |
|---|---|---|
| ECG screening (Zenicor-ECG) for atrial fibrillationDetermination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation. | Other | ECG screening |
Primary outcome
Incidence of stroke or systemic embolism in the control group vs the intervention group
Time frame: Five years
Endpoints collected from the Swedish patient registry will be compared between the groups
Incidence of stroke or systemic embolism in the control group vs the low-risk group (with NT-proBNP<125 ng/L and normal index 1-lead ECG).
Time frame: Five years
Endpoints collected from the Swedish patient registry will be compared between the groups
12 secondary outcomes
Incidence of major bleeding, ischaemic stroke, systemic embolism and death in the control group vs the intervention group
Time frame: Five years
Number of subjects with new discovered AF using intermittent ECG-recordings in the high risk Group with NT-proBNP>125 ng/L.
Time frame: Two years
To assess screening uptake with regards to socio-demographic factors and to study if we can improve uptake in the screening programme by decentralizing the recruitment procedure.
Time frame: Two years
Cost per gained quality-adjusted life-year (QALY) and cost per avoided stroke of the STROKESTOP II screening program.
Time frame: Five years
Plasma and serum biomarkers and their relation to incidence of new AF and short episodes of AF (micro-AF)
Time frame: Five years
To assess the incidence of heart failure in patients with NT-proBNP>125ng/L
Time frame: Five years
To study atrial function in patients with and without silent atrial fibrillation
Time frame: Five years
To study the correlation between symptoms and newly discovered AF
Time frame: Four years
To study the diagnostic performance of pulse-palpation in AF screening as compared to one-lead ECG
Time frame: Four years
To study the association of very short episodes of AF (micro-AF, episodes lasting shorter than 30 seconds) and incident AF
Time frame: Two years
To compare different ECG modalities for AF screening
Time frame: Two years
Incidence of undiagnosed hypertension in participants
Time frame: four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Derived from this study: PubMed 39217615Kemp Gudmundsdottir K, Svennberg E, Friberg L, Hygrell T, Frykman V, Al-Khalili F, Hijazi Z, Rosenqvist M, Engdahl J. Randomized Invitation to Systematic NT-proBNP and ECG Screening in 75-Year-Olds to Detect Atrial Fibrillation: STROKESTOP II. Circulation. 2024 Dec 3;150(23):1837-1846. doi: 10.1161/CIRCULATIONAHA.124.071176. Epub 2024 Sep 1.
- Derived from this study: PubMed 32276611Fredriksson T, Gudmundsdottir KK, Frykman V, Friberg L, Al-Khalili F, Engdahl J, Svennberg E. Brief episodes of rapid irregular atrial activity (micro-AF) are a risk marker for atrial fibrillation: a prospective cohort study. BMC Cardiovasc Disord. 2020 Apr 10;20(1):167. doi: 10.1186/s12872-020-01453-w.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Mårten Rosenqvist, MD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Stroke, run by Karolinska University Hospital at 1 site 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 1 inclusion and 1 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of stroke or systemic embolism in the control group vs the intervention group (time frame: Five years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02743416, which also lists 2 linked publications.
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 25 Nov 2020.