Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study

NCT05898165 | Active Not Recruiting

• 1 other identifier: 318197_V1.0_230509
• Study Type: observational
• Target: 1,955
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to trial a new intervention - risk-guided AF screening using an EHR-based risk score and remote ECG monitoring process - and to characterise individuals at elevated predicted AF risk.

Conditions

Atrial Fibrillation; Heart Diseases; Cardiovascular Diseases

Keywords

Computation; Data Science; Atrial fibrillation; Stroke

Outcome Measures

Primary Outcomes (3)

• To determine whether detection rates of AF during ECG monitoring are higher amongst participants identified as higher risk of AF, compared with those identified as lower risk

  Rate ratio of AF detection rates during ECG monitoring in participants identified as higher risk by FIND-AF compared with participants identified as lower risk

  6 months

• To determine whether detection rates of AF during ECG monitoring are higher amongst participants identified as higher risk of AF, compared with those identified as lower risk

  Rate ratio of AF detection rates during ECG monitoring in participants identified as higher risk by FIND-AF compared with participants identified as lower risk

  5 years

• To determine whether detection rates of AF during ECG monitoring are higher amongst participants identified as higher risk of AF, compared with those identified as lower risk

  Rate ratio of AF detection rates during ECG monitoring in participants identified as higher risk by FIND-AF compared with participants identified as lower risk

  10 years

Secondary Outcomes (3)

• To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription

  6 months

• To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription

  5 years

• To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription

  10 years

Other Outcomes (16)

• To determine the AF detection rates amongst participants who are identified as higher risk and lower risk, including in the periods outside of ECG monitoring to determine the incremental yield that is achieved by ECG monitoring over routine care

  6 months

• To determine how diagnostic yield, C statistic/AUROC, NPV, PPV, sensitivity and specificity, varies at different cut off points of the FIND-AF risk score

  6 months

• To determine the C statistic/AUROC, NPV, PPV, sensitivity and specificity for alternative approaches to guide systematic AF screening in participants who receive ECG monitoring:

  6 months

Interventions

Development of an algorithm OTHER

Prospective verification of a developed algorithm to predict the risk of a new onset Atrial Fibrillation

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged \>30 will be invited to screening in primary care from information present in their electronic health record (EHR) and their FIND-AF score. They will be given Zenicor ECG devices for up to period of 3 week during which they will be asked to record 4 daily ECG recordings. Those patients who are higher risk for AF based on their FIND-AF score, will be reviewed further for multi-modal phenotyping. Patient with new AF detected will be managed by their primary care clinicians.

You may qualify if:

• Age at enrolment ≥30 years
• Men with CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3

You may not qualify if:

• Known diagnosis of AF
• On anticoagulation therapy
• On the palliative care register
• Unable to give written informed consent for participation in the study
• Unable to adhere to the study requirements

Sponsors & Collaborators

• University of Leeds: lead
• British Heart Foundation: collaborator
• Daiichi Sankyo: collaborator
• The Leeds Teaching Hospitals NHS Trust: collaborator

Study Sites (1)

University of Leeds

Leeds, West Yorkshire, LS2 9JT, United Kingdom

Location

Related Publications (2)

• Hamilton E, Shone L, Reynolds C, Wu J, Nadarajah R, Gale C. Perceptions of healthcare professionals on the use of a risk prediction model to inform atrial fibrillation screening: qualitative interview study in English primary care. BMJ Open. 2025 Feb 5;15(2):e091675. doi: 10.1136/bmjopen-2024-091675.

  PMID: 39909527 DERIVED

• Nadarajah R, Wahab A, Reynolds C, Raveendra K, Askham D, Dawson R, Keene J, Shanghavi S, Lip GYH, Hogg D, Cowan C, Wu J, Gale CP. Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): pilot study of an electronic health record machine learning algorithm-guided intervention to identify undiagnosed atrial fibrillation. Open Heart. 2023 Sep;10(2):e002447. doi: 10.1136/openhrt-2023-002447.

  PMID: 37777255 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Heart Diseases; Cardiovascular Diseases; Stroke

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Chris Gale, Yes

  University of Leeds

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiovascular Medicine

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 12, 2023
• Study Start: October 1, 2023
• Primary Completion: June 16, 2025
• Study Completion: February 28, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)