An interventional study of ECG screening for atrial fibrillation using intermittent ECG recorder in Atrial Fibrillation and Stroke, sponsored by Karolinska University Hospital. Status unknown at 1 site in Sweden. Open to participants aged 75 Years to 76 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Prevention
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.
3,957 studies on the registry are indexed under Atrial Fibrillation; 933 are open to participants now.
This study's enrollment of 7,173 is above the median of 145 across 2,437 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Karolinska University Hospital is the lead sponsor of 278 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks
Other: ECG screening for atrial fibrillation using intermittent ECG recorder
Standard of care
ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
Also known as: Zenicor ECG recorder
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
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
This study is status unknown, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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