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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04045639

Acronym

PULsE AI

Enrollment

260

Registered

2019-08-05

Start date

2019-06-30

Completion date

2021-01-12

Last updated

2021-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

30 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United Kingdom

Outcome results