Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden

Study Overview
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Brief Summary
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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.

Official Title
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Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.

Conditions
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Atrial Fibrillation, Stroke

Intervention / Treatment
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* Other: ECG screening for atrial fibrillation using intermittent ECG recorder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women 75-76 years of age living in the region of Stockholm or Halland Exclusion Criteria: Not fulfilling the inclusion criteria

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ECG screening<br>Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks | Other: ECG screening for atrial fibrillation using intermittent ECG recorder<br>* ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.<br>* Other names: Zenicor ECG recorder;|
| No Intervention: Control group<br>Standard of care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Stroke prevention, Cost effectiveness