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

Not Applicable

• Conditions: Atrial Fibrillation; Stroke
• Interventions: Other: ECG screening for atrial fibrillation using intermittent ECG recorder

• Registration Number: NCT01593553
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-17
• Last Update Posted: 2017-11-20
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 7173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ECG screening	ECG screening for atrial fibrillation using intermittent ECG recorder	Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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	Five years. Interim analysis after 3 years.	Incidence of ischaemic stroke 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 participating in screening (as treated) 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
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
Dementia	Five years. Interim analysis after 3 years.	Incidence of dementia 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
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

Trial Locations

Locations (1)

Karolinska Trial Alliance, KTA Prim; 🇸🇪 Stockholm, Sweden