Atrial FibrillationNCT01593553
Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden
A study testing ECG screening for atrial fibrillation using intermittent ECG recorder in people with Atrial Fibrillation and Stroke, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke. 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 for atrial fibrillation using intermittent ECG recorder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7,173 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2012to Mar 2019
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women 75-76 years of age living in the region of Stockholm or Halland
Who cannot join
- Not fulfilling the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- ECG screening for atrial fibrillation using intermittent ECG recorder
- 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 for atrial fibrillation using intermittent ECG recorderOther
Also called Zenicor ECG recorder
ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| ECG screening | Experimental | Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks Receives: Other: ECG screening for atrial fibrillation using intermittent ECG recorder |
| Control group | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
A composite endpoint of incidence of ischamemic and haemorrhagic stroke, incidence of systemic embolism, major bleeding requiring hospitalization and all cause mortality in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Secondary outcomes (12)
Ischaemic stroke
Incidence of ischaemic stroke in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Ischaemic stroke and systemic thromboembolism
Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Ischaemic stroke and systemic thromboembolism
Incidence of ischaemic stroke and systemic thromboembolism in the group participating in screening (as treated) compared to the control group
Measured: Five years. Interim analysis after 3 years.
Dementia
Incidence of dementia in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
All cause mortality
All cause mortality in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Cardiovascular mortality
Cardiovascular in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Hospitalization due to cardiovascular disease
Hospitalization due to cardiovascular disease in the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause
In the group randomized to screening compared to the control group
Measured: Five years. Interim analysis after 3 years.
Cost effectivity
Measured: Five years
Initiation and compliance to oral anticoagulation therapy
The National Prescription Drug's register will be used to study intiation and duration of oral anticoagulation therapy in a as-treated and per-protocol analysis in the screened population compared to the control group
Measured: Five years
Detection of atrial fibrillation
Incidence of atrial fibrillation in the group randomized to screening compared to the control group
Measured: Five years
Pulmonary embolism and deep vein thrombosis
Incidence of pulmonary embolism and deep vein thrombosis in the group randomized to screening compared to the control group
Measured: Five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 7,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Mårten Rosenqvist, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593553
- Sponsor's protocol ID
- Strokestop
- Status last verified
- Nov 2017
- First submitted
- 4 May 2012
- Last updated
- 20 Nov 2017
- Results posted
- No
Publications
Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M. Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1498-1506. doi: 10.1016/S0140-6736(21)01637-8. Epub 2021 Aug 29.
PubMed 34469764Hygrell T, Stridh M, Friberg L, Svennberg E. Prognostic Implications of Supraventricular Arrhythmias. Am J Cardiol. 2021 Jul 15;151:57-63. doi: 10.1016/j.amjcard.2021.04.020.
PubMed 34167689Svennberg E, Henriksson P, Engdahl J, Hijazi Z, Al-Khalili F, Friberg L, Frykman V. N-terminal pro B-type natriuretic peptide in systematic screening for atrial fibrillation. Heart. 2017 Aug;103(16):1271-1277. doi: 10.1136/heartjnl-2016-310236. Epub 2017 Mar 2.
PubMed 28255099Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
PubMed 25910800
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
- ClinicalTrials.gov ID
- NCT01593553
- Acronym / sponsor ID
- Strokestop
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Screening, Stroke prevention, Cost effectiveness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7,173 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 8 May 2012 (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.
The purpose of this study is to determine whether screening for atrial fibrillation by intermittent ECG recording and initiation of anticoagulation treatment among high risk individuals is cost-effective and can lower the incidence of stroke.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECG screening | Experimental | Other: ECG screening for atrial fibrillation using intermittent ECG recorderTwice daily screening using intermittent ECG recorder (Zenicor) for two weeks |
| Control group | No intervention | –Standard of care |
Who may qualify
- Ages
- 75 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Men and women 75-76 years of age living in the region of Stockholm or Halland
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 for atrial fibrillation using intermittent ECG recorderAlso: Zenicor ECG recorderECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation. | Other | ECG screening |
Primary outcome
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
Time frame: Five years. Interim analysis after 3 years.
A composite endpoint of incidence of ischamemic and haemorrhagic stroke, incidence of systemic embolism, major bleeding requiring hospitalization and all cause mortality in the group randomized to screening compared to the control group
12 secondary outcomes
Ischaemic stroke
Time frame: Five years. Interim analysis after 3 years.
Ischaemic stroke and systemic thromboembolism
Time frame: Five years. Interim analysis after 3 years.
Ischaemic stroke and systemic thromboembolism
Time frame: Five years. Interim analysis after 3 years.
Dementia
Time frame: Five years. Interim analysis after 3 years.
All cause mortality
Time frame: Five years. Interim analysis after 3 years.
Cardiovascular mortality
Time frame: Five years. Interim analysis after 3 years.
Hospitalization due to cardiovascular disease
Time frame: Five years. Interim analysis after 3 years.
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause
Time frame: Five years. Interim analysis after 3 years.
Cost effectivity
Time frame: Five years
Initiation and compliance to oral anticoagulation therapy
Time frame: Five years
Detection of atrial fibrillation
Time frame: Five years
Pulmonary embolism and deep vein thrombosis
Time frame: Five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Derived from this study: PubMed 34469764Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M. Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1498-1506. doi: 10.1016/S0140-6736(21)01637-8. Epub 2021 Aug 29.
- Derived from this study: PubMed 34167689Hygrell T, Stridh M, Friberg L, Svennberg E. Prognostic Implications of Supraventricular Arrhythmias. Am J Cardiol. 2021 Jul 15;151:57-63. doi: 10.1016/j.amjcard.2021.04.020.
- Derived from this study: PubMed 28255099Svennberg E, Henriksson P, Engdahl J, Hijazi Z, Al-Khalili F, Friberg L, Frykman V. N-terminal pro B-type natriuretic peptide in systematic screening for atrial fibrillation. Heart. 2017 Aug;103(16):1271-1277. doi: 10.1136/heartjnl-2016-310236. Epub 2017 Mar 2.
- Derived from this study: PubMed 25910800Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG screening for atrial fibrillation using intermittent ECG recorder in people with 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 20 Nov 2017. 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?
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause (time frame: Five years. Interim analysis after 3 years.). 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 NCT01593553, which also lists 4 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 20 Nov 2017.