NCT01593553

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7,173

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

November 20, 2017

Status Verified

November 1, 2017

Enrollment Period

7 years

First QC Date

May 4, 2012

Last Update Submit

November 17, 2017

Conditions

Atrial FibrillationStroke

Keywords

ScreeningStroke preventionCost effectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Ischaemic stroke

    Five years. Interim analysis after 3 years.

  • Ischaemic stroke and systemic thromboembolism

    Five years. Interim analysis after 3 years.

  • Ischaemic stroke and systemic thromboembolism

    Five years. Interim analysis after 3 years.

  • Dementia

    Five years. Interim analysis after 3 years.

  • All cause mortality

    Five years. Interim analysis after 3 years.

  • +7 more secondary outcomes

Study Arms (2)

ECG screening

EXPERIMENTAL

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

Other: ECG screening for atrial fibrillation using intermittent ECG recorder

Control group

NO INTERVENTION

Standard of care

Interventions

ECG screening for atrial fibrillation using intermittent ECG recorderOTHER

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

Also known as: Zenicor ECG recorder
ECG screening

Eligibility Criteria

Age75 Years - 76 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Men and women 75-76 years of age living in the region of Stockholm or Halland

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Trial Alliance, KTA Prim

Stockholm, 11361, Sweden

Location

Related Publications (4)

  • 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.

    PMID: 34469764DERIVED

  • 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.

    PMID: 34167689DERIVED

  • 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.

    PMID: 28255099DERIVED

  • 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.

    PMID: 25910800DERIVED

MeSH Terms

Conditions

Atrial FibrillationStroke

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

November 20, 2017

Record last verified: 2017-11

Locations

SE(1)