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

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT04045639
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2019-06-30
• Study First Submitted: 2019-07-23
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Primary Completion: 2021-01-12
• Study Completion: 2021-01-12
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

Practice inclusion criteria for the trial are as follows;

• GP Practices within National Institute for Healthcare Research (NIHR) Clinical Research Network: West Midlands (CRN: WM) CRN: WM
• GP Practices using EMIS as their electronic medical record system of choice. Patient inclusion criteria for the trial are as follows;
• Patients registered at a participating practice, aged ≥30 years and without an AF diagnosis.
• Patients with a valid index date (see Section 3.3) Participant inclusion criteria for participation in the intervention arm are;
• As above, and who have provided written consent to: attend a research clinic, AF diagnosis check using a 12-lead ECG, and for access to medical records Participant inclusion criteria for participation in further AF remote diagnosis with an AliveCor Heart Monitor are;
• 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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms	From the first collection of patient medical records at the beginning of the trial to the last collection of patient records following the intervention at the end of the trial (Up to 6 months)	Prevalence of AF in the research window assessed

Secondary Outcome Measures

Name	Time	Method
Expected healthcare resource utilisation (Annual maintenance costs related to health states (informed by the primary endpoint), and daily treatment costs (including monitoring))	Up to 6 months
Quality-adjusted life years (QALYs)	Up to 6 months
Life years (LYs)	Up to 6 months

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Worcester, United Kingdom