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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 : Unknown
Verified November 2017 by Professor Mårten Rosenqvist, Karolinska University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : November 20, 2017
Sponsor:
Information provided by (Responsible Party):
Professor Mårten Rosenqvist, Karolinska University Hospital

Tracking Information
First Submitted Date  ICMJE May 4, 2012
First Posted Date  ICMJE May 8, 2012
Last Update Posted Date November 20, 2017
Study Start Date  ICMJE March 2012
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Reduced incidence of stroke among 75 year old subjects. [ Time Frame: Five years. Interim analysis after 3 years. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2017)
  • 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
  • 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
  • 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
  • Dementia [ Time Frame: Five years. Interim analysis after 3 years. ]
    Incidence of dementia in the group randomized to screening compared to the control group
  • 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
  • Cardiovascular mortality [ Time Frame: Five years. Interim analysis after 3 years. ]
    Cardiovascular in the group randomized to screening compared to the control group
  • 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
  • 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
  • Cost effectivity [ Time Frame: 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
  • Detection of atrial fibrillation [ Time Frame: Five years ]
    Incidence of atrial fibrillation in the group randomized to screening compared to the control group
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
Cost effectivity [ Time Frame: Five years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden
Official Title  ICMJE Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: ECG screening
    Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks
    Intervention: Other: ECG screening for atrial fibrillation using intermittent ECG recorder
  • No Intervention: Control group
    Standard of care
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 30, 2016)
7173
Original Estimated Enrollment  ICMJE
 (submitted: May 7, 2012)
6500
Estimated Study Completion Date  ICMJE March 2019
Estimated Primary Completion Date March 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 75 Years to 76 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01593553
Other Study ID Numbers  ICMJE Strokestop
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Professor Mårten Rosenqvist, Karolinska University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Karolinska University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska University Hospital
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP