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

Karolinska University Hospital1 site in 1 country7,173 target enrollmentMarch 2012

ConditionsAtrial Fibrillation Stroke

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Karolinska University Hospital
Enrollment: 7173
Locations: 1
Primary Endpoint: Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2012

End Date

March 2019

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karolinska University Hospital

Responsible Party

Principal Investigator

Professor Mårten Rosenqvist

Professor

Karolinska University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause

Time Frame: 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 Outcomes

Hospitalization due to cardiovascular disease(Five years. Interim analysis after 3 years.)
Ischaemic stroke(Five years. Interim analysis after 3 years.)
Ischaemic stroke and systemic thromboembolism(Five years. Interim analysis after 3 years.)
All cause mortality(Five years. Interim analysis after 3 years.)
Cardiovascular mortality(Five years. Interim analysis after 3 years.)
Detection of atrial fibrillation(Five years)
Pulmonary embolism and deep vein thrombosis(Five years)
Dementia(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(Five years. Interim analysis after 3 years.)
Cost effectivity(Five years)
Initiation and compliance to oral anticoagulation therapy(Five years)