A Study to Assess the Effectiveness of an Atrial Fibrillation (AF) Risk Prediction Algorithm and Diagnostic Test in Identifying Patients With AF.

NCT ID: NCT04045639

Last Updated: 2021-08-02

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

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-30

Study Completion Date

2021-01-12

Brief Summary

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This is a trial to assess the effectiveness of an atrial fibrillation (AF) risk prediction algorithm and diagnostic test for the identification of patients with atrial fibrillation

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intervention arm

The AF risk prediction algorithm will be run on patient records within the Egton Medical Information Systems (EMIS) data base, in order to identify patients at risk of developing AF

No interventions assigned to this group

Control arm

Patients may be diagnosed with AF through routine clinical practice only

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM
* Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis.
* As above, and those with a negative or indeterminant ECG
* As above, and those with access to a smartphone

Exclusion Criteria

* Patients \<30 years
* Patients with an existing diagnosis of AF
* Patients for whom the healthcare professional feels the study is unsuitable
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Ludlow, , United Kingdom

Site Status

Local Institution

Royal Leamington Spa, , United Kingdom

Site Status

Local Institution

Shropshire, , United Kingdom

Site Status

Local Institution

Warkwickshire, , United Kingdom

Site Status

Local Institution

Wolverhampton, , United Kingdom

Site Status

Local Institution

Worcester, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Hill NR, Arden C, Beresford-Hulme L, Camm AJ, Clifton D, Davies DW, Farooqui U, Gordon J, Groves L, Hurst M, Lawton S, Lister S, Mallen C, Martin AC, McEwan P, Pollock KG, Rogers J, Sandler B, Sugrue DM, Cohen AT. Identification of undiagnosed atrial fibrillation patients using a machine learning risk prediction algorithm and diagnostic testing (PULsE-AI): Study protocol for a randomised controlled trial. Contemp Clin Trials. 2020 Dec;99:106191. doi: 10.1016/j.cct.2020.106191. Epub 2020 Oct 19.

Reference Type DERIVED
PMID: 33091585 (View on PubMed)

Related Links

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Other Identifiers

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CV185-703

Identifier Type: -

Identifier Source: org_study_id

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