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

NCT ID: NCT01593553

Last Updated: 2017-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2019-03-31

Brief Summary

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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

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Conditions

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Atrial Fibrillation Stroke

Keywords

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Screening Stroke prevention Cost effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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ECG screening

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

Group Type EXPERIMENTAL

ECG screening for atrial fibrillation using intermittent ECG recorder

Intervention Type OTHER

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

Control group

Standard of care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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Zenicor ECG recorder

Eligibility Criteria

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Inclusion Criteria

* Men and women 75-76 years of age living in the region of Stockholm or Halland
Minimum Eligible Age

75 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Professor Mårten Rosenqvist

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karolinska Trial Alliance, KTA Prim

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34469764 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34167689 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28255099 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25910800 (View on PubMed)

Other Identifiers

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Strokestop

Identifier Type: -

Identifier Source: org_study_id