Atrial FibrillationPULsE AINCT04045639
A Study to Assess the Effectiveness of an Atrial Fibrillation (AF) Risk Prediction Algorithm and Diagnostic Test in Identifying Patients With AF.
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 6 sites in United Kingdom.
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 Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 260 participants
- Where
- 6 sitesUnited Kingdom
- Study dates
- 30 Jun 2019to 12 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Adult, Older adult
Study population: It is anticipated that approximately 18,000 patient records will be included in the trial. It is anticipated that approximately 1,200 undiagnosed patients would be invited for AF diagnosis across all study sites.30 years is taken as the minimum age entry criteria as the algorithm was built on information from patients >30 years where AF becomes more prevalent.
Who may be able to join
- 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
Who cannot join
- Patients <30 years
- Patients with an existing diagnosis of AF
- Patients for whom the healthcare professional feels the study is unsuitable
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United Kingdom6 sites
Local Institution
Ludlow, SY8 2AB
Local Institution
Royal Leamington Spa, CV32 4RA
Local Institution
Shropshire, SY11 1RD
Local Institution
Warkwickshire, B49 6QR
Local Institution
Wolverhampton, WV10 8RN
Local Institution
Worcester, WR1 2BS
About this study
Official title: A Randomised Controlled Trial for the Identification of Undiagnosed Atrial Fibrillation Patients Using a Machine Learning Risk Prediction Algorithm and Diagnostic Test
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
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| Control arm | Patients may be diagnosed with AF through routine clinical practice only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants with diagnosed Atrial Fibrillation during the research window in control and intervention arms
Prevalence of AF in the research window assessed
Measured: 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 outcomes (3)
Expected healthcare resource utilisation (Annual maintenance costs related to health states (informed by the primary endpoint), and daily treatment costs (including monitoring))
Measured: Up to 6 months
Quality-adjusted life years (QALYs)
Measured: Up to 6 months
Life years (LYs)
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start30 Jun 2019
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045639
- Sponsor's protocol ID
- CV185-703
- Acronym
- PULsE AI
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2019
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33091585
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial for the Identification of Undiagnosed Atrial Fibrillation Patients Using a Machine Learning Risk Prediction Algorithm and Diagnostic Test
- ClinicalTrials.gov ID
- NCT04045639
- Acronym / sponsor ID
- PULsE AI / CV185-703
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2019 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Control arm | – | –Patients may be diagnosed with AF through routine clinical practice only |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- It is anticipated that approximately 18,000 patient records will be included in the trial. It is anticipated that approximately 1,200 undiagnosed patients would be invited for AF diagnosis across all study sites.30 years is taken as the minimum age entry criteria as the algorithm was built on information from patients >30 years where AF becomes more prevalent.
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- Patients <30 years
- Patients with an existing diagnosis of AF
- Patients for whom the healthcare professional feels the study is unsuitable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
Quality-adjusted life years (QALYs)
Time frame: Up to 6 months
Life years (LYs)
Time frame: Up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Derived from this study: PubMed 33091585Hill 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.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Bristol-Myers Squibb at 6 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04045639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.