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

Atrial Fibrillation Clinical Trial

— PULsE AI  

Official title:

A Randomised Controlled Trial for the Identification of Undiagnosed Atrial Fibrillation Patients Using a Machine Learning Risk Prediction Algorithm and Diagnostic Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04045639
• Other study ID #: CV185-703
• Status: Completed
• Start date: June 30, 2019
• Est. completion date: January 12, 2021

Study information

• Verified date: July 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: January 12, 2021
• Est. primary completion date: January 12, 2021
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
United Kingdom	Local Institution	Leamington Spa
United Kingdom	Local Institution	Ludlow
United Kingdom	Local Institution	Shropshire
United Kingdom	Local Institution	Warkwickshire
United Kingdom	Local Institution	Wolverhampton
United Kingdom	Local Institution	Worcester

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms	Prevalence of AF in the research window assessed	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)
Secondary	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
Secondary	Quality-adjusted life years (QALYs)		Up to 6 months
Secondary	Life years (LYs)		Up to 6 months

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls