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

November 17, 2017 updated by: Professor Mårten Rosenqvist, Karolinska University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11361
        • Karolinska Trial Alliance, KTA Prim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

75 years to 76 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Standard of care
Experimental: ECG screening
Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks
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.
Other Names:
  • Zenicor ECG recorder

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Five years. Interim analysis after 3 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischaemic stroke
Time Frame: Five years. Interim analysis after 3 years.
Incidence of ischaemic stroke in the group randomized to screening compared to the control group
Five years. Interim analysis after 3 years.
Ischaemic stroke and systemic thromboembolism
Time Frame: Five years. Interim analysis after 3 years.
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.
Ischaemic stroke and systemic thromboembolism
Time Frame: 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
Five years. Interim analysis after 3 years.
Dementia
Time Frame: Five years. Interim analysis after 3 years.
Incidence of dementia in the group randomized to screening compared to the control group
Five years. Interim analysis after 3 years.
All cause mortality
Time Frame: Five years. Interim analysis after 3 years.
All cause mortality in the group randomized to screening compared to the control group
Five years. Interim analysis after 3 years.
Cardiovascular mortality
Time Frame: Five years. Interim analysis after 3 years.
Cardiovascular in the group randomized to screening compared to the control group
Five years. Interim analysis after 3 years.
Hospitalization due to cardiovascular disease
Time Frame: Five years. Interim analysis after 3 years.
Hospitalization due to cardiovascular disease in the group randomized to screening compared to the control group
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
Time Frame: Five years. Interim analysis after 3 years.
In the group randomized to screening compared to the control group
Five years. Interim analysis after 3 years.
Cost effectivity
Time Frame: Five years
Five years
Initiation and compliance to oral anticoagulation therapy
Time Frame: 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
Five years
Detection of atrial fibrillation
Time Frame: Five years
Incidence of atrial fibrillation in the group randomized to screening compared to the control group
Five years
Pulmonary embolism and deep vein thrombosis
Time Frame: Five years
Incidence of pulmonary embolism and deep vein thrombosis in the group randomized to screening compared to the control group
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

May 4, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 17, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Strokestop

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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