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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECG screening | Experimental | Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks |
|
| Control group | No Intervention | Standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ECG screening for atrial fibrillation using intermittent ECG recorder | Other | ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Five years. Interim analysis after 3 years. |
| Measure | Description | Time Frame |
|---|---|---|
| Ischaemic stroke | Incidence of ischaemic stroke in the group randomized to screening compared to the control group | Five years. Interim analysis after 3 years. |
| Ischaemic stroke and systemic thromboembolism |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Trial Alliance, KTA Prim | Stockholm | 11361 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34469764 | Derived | 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. | |
| 34167689 |
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|
Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group
| 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 | Five years. Interim analysis after 3 years. |
| Dementia | Incidence of dementia in the group randomized to screening compared to the control group | Five years. Interim analysis after 3 years. |
| All cause mortality | All cause mortality in the group randomized to screening compared to the control group | Five years. Interim analysis after 3 years. |
| Cardiovascular mortality | Cardiovascular in the group randomized to screening compared to the control group | 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 | 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 | Five years. Interim analysis after 3 years. |
| Cost effectivity | 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 | Five years |
| Detection of atrial fibrillation | Incidence of atrial fibrillation in the group randomized to screening compared to the control group | 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 | Five years |
| Hygrell 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. |
| 28255099 | Derived | Svennberg 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. |
| 25910800 | Derived | Svennberg 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. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
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