Atrial Fibrillation, Stroke
Conditions
Keywords
Screening, Stroke prevention, Cost effectiveness
Brief 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.
Interventions
OTHERECG screening for atrial fibrillation using intermittent 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.
Sponsors
Karolinska University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
75 Years to 76 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dementia | Five years. Interim analysis after 3 years. | Incidence of dementia in the group randomized to screening compared to the control group |
| Ischaemic stroke | Five years. Interim analysis after 3 years. | Incidence of ischaemic stroke in the group randomized to screening compared to the control group |
| All cause mortality | Five years. Interim analysis after 3 years. | All cause mortality in the group randomized to screening compared to the control group |
| Cardiovascular mortality | Five years. Interim analysis after 3 years. | Cardiovascular in the group randomized to screening compared to the control group |
| Hospitalization due to cardiovascular disease | Five years. Interim analysis after 3 years. | Hospitalization due to cardiovascular disease in the group randomized to screening compared to the control group |
| Ischaemic stroke and systemic thromboembolism | Five years. Interim analysis after 3 years. | Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group |
| Cost effectivity | Five years | — |
| Initiation and compliance to oral anticoagulation therapy | Five years | 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 |
| Detection of atrial fibrillation | Five years | Incidence of atrial fibrillation in the group randomized to screening compared to the control group |
| Pulmonary embolism and deep vein thrombosis | Five years | Incidence of pulmonary embolism and deep vein thrombosis in the group randomized to screening compared to the control group |
| Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause | Five years. Interim analysis after 3 years. | In the group randomized to screening compared to the control group |
Countries
Sweden
Outcome results
None listed