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OpenTrials
Completed

NCT Number: NCT04045639

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

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution, Ludlow, United Kingdom

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms

    Time frame: 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 outcomes

  1. Expected healthcare resource utilisation (Annual maintenance costs related to health states (informed by the primary endpoint), and daily treatment costs (including monitoring))

    Time frame: Up to 6 months

  2. Quality-adjusted life years (QALYs)

    Time frame: Up to 6 months

  3. Life years (LYs)

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Acronym: PULsE AI

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 5, 2019
Registry last updated
Aug 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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