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

Active, not recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • ECG screening for atrial fibrillation Other
    Intervention Desc: ECG screening for atrial fibrillation with intermittent ECG recording for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
    ARM 1: Kind: Experimental
    Label: ECG screening
  • ECG screening for atrial fibrillation using intermittent ECG recorder Other
    Other Names: Zenicor ECG recorder
    Intervention Desc: ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
    ARM 1: Kind: Experimental
    Label: ECG screening
    Description: Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Reduced incidence of stroke among 75 year old subjects. Five years. Interim analysis after 3 years. Yes
Secondary Cost effectivity Five years No
Primary Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause Five years. Interim analysis after 3 years.
Secondary Ischaemic stroke Five years. Interim analysis after 3 years.
Secondary Ischaemic stroke and systemic thromboembolism Five years. Interim analysis after 3 years.
Secondary Dementia Five years. Interim analysis after 3 years.
Secondary All cause mortality Five years. Interim analysis after 3 years.
Secondary Cardiovascular mortality Five years. Interim analysis after 3 years.
Secondary Hospitalization due to cardiovascular disease Five years. Interim analysis after 3 years.
Secondary 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.
Secondary Initiation and compliance to oral anticoagulation therapy Five years
Secondary Detection of atrial fibrillation Five years
Secondary Pulmonary embolism and deep vein thrombosis Five years

Sponsors