Clinical trial NCT05898165: Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study
Official title: Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF): Pilot Study of a Risk Score for Early Detection of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Keywords: Computation
Data Science
Atrial fibrillation
Stroke
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: British Heart Foundation
name: Daiichi Sankyo
name: The Leeds Teaching Hospitals NHS Trust
First posted: 2023-06-12
Enrollment: 1955
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 5 years
measure: 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
timeFrame: 10 years
Secondary outcomes:
measure: To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
timeFrame: 6 months
measure: To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
timeFrame: 5 years
measure: To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
timeFrame: 10 years
Other outcomes:
measure: 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
timeFrame: 6 months
measure: 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
timeFrame: 6 months
measure: 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:
timeFrame: 6 months
measure: To determine if yield from ECG monitoring varies across age groups (≥75 years and ≤75 years) and sex (men and women)
timeFrame: 6 months
measure: To determine recruitment rates, overall study.
timeFrame: Up to 24 months
measure: To determine withdrawal rates
timeFrame: Up to 24 months
measure: To determine if there are differences between those who participate and those that do not participate
timeFrame: Up to 24 months
measure: To determine if there are differences between those who participate and those that withdraw
timeFrame: Up to 24 months
measure: To determine the adherence of ECG recordings amongst participants
timeFrame: Up to 24 months
measure: To determine the number of ECG recordings that need to be reviewed for possible AF detection
timeFrame: Up to 24 months
measure: To determine the burden of other arrhythmias that are diagnosed through ECG monitoring in participants identified as higher risk and lower risk
timeFrame: Up to 24 months
measure: To determine the burden of non-diagnostic rhythm reports from ECG monitoring
timeFrame: Up to 24 months
measure: To determine recruitment rates - research clinic appointment
timeFrame: Up to 24 months
measure: To determine what other conditions and cardiovascular risk factors are identified amongst participants classified as higher risk for AF at research clinic
timeFrame: End of recruitment
measure: To observe the clinical outcomes of participants that participate in the study, and whether there is a difference between participants identified as higher and lower risk?
timeFrame: 5 years from completion of recruitment
measure: To observe the clinical outcomes of participants that participate in the study, and whether there is a difference between participants identified as higher and lower risk?
timeFrame: 10 years from completion of recruitment
Locations:
city: Leeds
country: United Kingdom
facility: University of Leeds
state: West Yorkshire
Study officials:
affiliation: University of Leeds
name: Chris Gale, Yes
role: PRINCIPAL_INVESTIGATOR
References: