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

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ClinicalTrials.gov Identifier: NCT01593553
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Atrial Fibrillation Stroke Other: ECG screening for atrial fibrillation using intermittent ECG recorder

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7173 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
Study Start Date : March 2012
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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 Name: Zenicor ECG recorder
No Intervention: Control group
Standard of care


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Dementia [ Time Frame: Five years. Interim analysis after 3 years. ]
    Incidence of dementia in the group randomized to screening compared to the control group

  5. 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

  6. Cardiovascular mortality [ Time Frame: Five years. Interim analysis after 3 years. ]
    Cardiovascular in the group randomized to screening compared to the control group

  7. 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

  8. 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

  9. Cost effectivity [ Time Frame: Five years ]
  10. 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

  11. Detection of atrial fibrillation [ Time Frame: Five years ]
    Incidence of atrial fibrillation in the group randomized to screening compared to the control group

  12. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years to 76 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593553


Locations
Sweden
Karolinska Trial Alliance, KTA Prim
Stockholm, Sweden, 11361
Sponsors and Collaborators
Karolinska University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Mårten Rosenqvist, Professor, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT01593553     History of Changes
Other Study ID Numbers: Strokestop
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017

Keywords provided by Professor Mårten Rosenqvist, Karolinska University Hospital:
Screening
Stroke prevention
Cost effectiveness

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes