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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01593553
• Other study ID #: Strokestop
• Status: Active, not recruiting
• Phase: N/A
• First received: May 4, 2012
• Last updated: November 17, 2017
• Start date: March 2012
• Est. completion date: March 2019

Study information

• Verified date: November 2017
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7173
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years to 76 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Stroke

Intervention

Other:
• ECG screening for atrial fibrillation using intermittent ECG recorder
ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.

Locations

Country	Name	City	State
Sweden	Karolinska Trial Alliance, KTA Prim	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Five years. Interim analysis after 3 years.
Secondary	Ischaemic stroke	Incidence of ischaemic stroke in the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	Ischaemic stroke and systemic thromboembolism	Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	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	Five years. Interim analysis after 3 years.
Secondary	Dementia	Incidence of dementia in the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	All cause mortality	All cause mortality in the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	Cardiovascular mortality	Cardiovascular in the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	Hospitalization due to cardiovascular disease	Hospitalization due to cardiovascular disease in the group randomized to screening compared to the control group	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	In the group randomized to screening compared to the control group	Five years. Interim analysis after 3 years.
Secondary	Cost effectivity		Five years
Secondary	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	Five years
Secondary	Detection of atrial fibrillation	Incidence of atrial fibrillation in the group randomized to screening compared to the control group	Five years
Secondary	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	Five years