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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
7,173
ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
Karolinska Trial Alliance, KTA Prim
Stockholm, Sweden
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
Time frame: Five years. Interim analysis after 3 years.
Ischaemic stroke
Incidence of ischaemic stroke in the group randomized to screening compared to the control group
Time frame: 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
Time frame: 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
Time frame: Five years. Interim analysis after 3 years.
Dementia
Incidence of dementia in the group randomized to screening compared to the control group
Time frame: Five years. Interim analysis after 3 years.
All cause mortality
All cause mortality in the group randomized to screening compared to the control group
Time frame: Five years. Interim analysis after 3 years.
Cardiovascular mortality
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cardiovascular in the group randomized to screening compared to the control group
Time frame: 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
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
In the group randomized to screening compared to the control group
Time frame: Five years. Interim analysis after 3 years.
Cost effectivity
Time frame: 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
Time frame: Five years
Detection of atrial fibrillation
Incidence of atrial fibrillation in the group randomized to screening compared to the control group
Time frame: 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
Time frame: Five years