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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

1955 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-02-28

Brief Summary

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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.

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Detailed Description

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This pilot study will use a post-market device within its intended purpose and involve a change in standard care - that is the offer of ECG monitoring for individuals at risk of AF to understand whether this leads to an increase in detection rates of AF, and follow-through prescription of oral anticoagulation.

Starting with the population that are eligible for oral anticoagulation (men with a CHA2DS2VASC ≥ 2 and women with a CHA2DS2VASC ≥ 3), but without AF, this pilot study will use FIND-AF within its intended purpose to predict the absolute risk of AF diagnosis for individuals within the next 6 months. It will be observed whether systematic AF screening leads to higher detection rates of AF in individuals at higher risk for AF than individuals at lower risk for AF.

This will give pilot data for whether systematic screening for AF in individuals at higher AF risk results in an incrementally higher yield of AF detection compared with screening approaches that have been targeted by age and risk of AF-related stroke. If the pilot shows that detection rates for AF are higher in the group at higher AF risk, then it would be suitable to plan a randomised controlled trial to determine whether systematic AF screening guided by AF risk increases detection rates of AF compared with routine care, and whether this is associated with a lower rate of stroke. The detection rates during systematic AF screening in this pilot study for individuals at higher and lower risk can establish power calculations required for a full-scale study and whether the numeric score at which a clinician would implement the intervention can be optimised.

In addition, this pilot study will establish the technical, logistic and administrative feasibility of a full-scale remote AF screening study including issues of recruitment and protocol adherence. It will also inform as to whether individuals diagnosed with AF by systematic AF screening in the community will receive oral anticoagulation interventions in primary care, and thus whether treatment of screen-detected AF in a full-scale study should be implemented in primary care or in secondary care under cardiology.

Finally this study will offer participants at higher AF risk the opportunity to attend a research clinic to determine whether these individuals have risk factors and comorbidities that could be identified and treated to reduce their subsequent risk of AF and other adverse events. This will establish whether individuals at risk of AF will attend for review, and their burden of modifiable risk factors for AF. This will establish power calculations that would be required for a full-scale study to test the hypothesis that primary prevention of AF is possible through interventions aimed at individuals at risk of AF.

Conditions

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Atrial Fibrillation Heart Diseases Cardiovascular Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Development of an algorithm

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No