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

Primary Purpose

Atrial Fibrillation, Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
ECG screening for atrial fibrillation using intermittent ECG recorder
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Screening, Stroke prevention, Cost effectiveness

Eligibility Criteria

75 Years - 76 Years (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karolinska Trial Alliance, KTA Prim

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ECG screening

Control group

Arm Description

Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks

Standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Ischaemic stroke
Incidence of ischaemic stroke in the group randomized to screening compared to the control group
Ischaemic stroke and systemic thromboembolism
Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group
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
Dementia
Incidence of dementia in the group randomized to screening compared to the control group
All cause mortality
All cause mortality in the group randomized to screening compared to the control group
Cardiovascular mortality
Cardiovascular in the group randomized to screening compared to the control group
Hospitalization due to cardiovascular disease
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
In the group randomized to screening compared to the control group
Cost effectivity
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
Detection of atrial fibrillation
Incidence of atrial fibrillation in the group randomized to screening compared to the control group
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

Full Information

First Posted
May 4, 2012
Last Updated
November 17, 2017
Sponsor
Karolinska University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01593553
Brief Title
Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden
Official Title
Systematic ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm and Halland, Sweden.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
Screening, Stroke prevention, Cost effectiveness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ECG screening
Arm Type
Experimental
Arm Description
Twice daily screening using intermittent ECG recorder (Zenicor) for two weeks
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard of care
Intervention Type
Other
Intervention Name(s)
ECG screening for atrial fibrillation using intermittent ECG recorder
Other Intervention Name(s)
Zenicor ECG recorder
Intervention Description
ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
Primary Outcome Measure Information:
Title
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization or death from any cause
Description
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
Time Frame
Five years. Interim analysis after 3 years.
Secondary Outcome Measure Information:
Title
Ischaemic stroke
Description
Incidence of ischaemic stroke in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Ischaemic stroke and systemic thromboembolism
Description
Incidence of ischaemic stroke and systemic thromboembolism in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Ischaemic stroke and systemic thromboembolism
Description
Incidence of ischaemic stroke and systemic thromboembolism in the group participating in screening (as treated) compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Dementia
Description
Incidence of dementia in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
All cause mortality
Description
All cause mortality in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Cardiovascular mortality
Description
Cardiovascular in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Hospitalization due to cardiovascular disease
Description
Hospitalization due to cardiovascular disease in the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Ischaemic or haemorrhagic stroke, systemic embolism, major bleeding leading to hospitalization, hospitalization due to cardiovascular disease or death from any cause
Description
In the group randomized to screening compared to the control group
Time Frame
Five years. Interim analysis after 3 years.
Title
Cost effectivity
Time Frame
Five years
Title
Initiation and compliance to oral anticoagulation therapy
Description
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
Time Frame
Five years
Title
Detection of atrial fibrillation
Description
Incidence of atrial fibrillation in the group randomized to screening compared to the control group
Time Frame
Five years
Title
Pulmonary embolism and deep vein thrombosis
Description
Incidence of pulmonary embolism and deep vein thrombosis in the group randomized to screening compared to the control group
Time Frame
Five years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
75 Years
Maximum Age & Unit of Time
76 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Karolinska Trial Alliance, KTA Prim
City
Stockholm
ZIP/Postal Code
11361
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
34469764
Citation
Svennberg E, Friberg L, Frykman V, Al-Khalili F, Engdahl J, Rosenqvist M. Clinical outcomes in systematic screening for atrial fibrillation (STROKESTOP): a multicentre, parallel group, unmasked, randomised controlled trial. Lancet. 2021 Oct 23;398(10310):1498-1506. doi: 10.1016/S0140-6736(21)01637-8. Epub 2021 Aug 29.
Results Reference
derived
PubMed Identifier
34167689
Citation
Hygrell T, Stridh M, Friberg L, Svennberg E. Prognostic Implications of Supraventricular Arrhythmias. Am J Cardiol. 2021 Jul 15;151:57-63. doi: 10.1016/j.amjcard.2021.04.020.
Results Reference
derived
PubMed Identifier
28255099
Citation
Svennberg E, Henriksson P, Engdahl J, Hijazi Z, Al-Khalili F, Friberg L, Frykman V. N-terminal pro B-type natriuretic peptide in systematic screening for atrial fibrillation. Heart. 2017 Aug;103(16):1271-1277. doi: 10.1136/heartjnl-2016-310236. Epub 2017 Mar 2.
Results Reference
derived
PubMed Identifier
25910800
Citation
Svennberg E, Engdahl J, Al-Khalili F, Friberg L, Frykman V, Rosenqvist M. Mass Screening for Untreated Atrial Fibrillation: The STROKESTOP Study. Circulation. 2015 Jun 23;131(25):2176-84. doi: 10.1161/CIRCULATIONAHA.114.014343. Epub 2015 Apr 24.
Results Reference
derived

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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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