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Innovations futures dans la nouvelle détection de la fibrillation auriculaire (FIND-AF) : étude pilote (FIND-AF)

30 septembre 2026 mis à jour par: Prof Christopher Gale, University of Leeds

Future Innovations in Novel Detection for Atrial Fibrillation (FIND-AF) : étude pilote d'un score de risque pour la détection précoce de la fibrillation auriculaire

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.

Aperçu de l'étude

Statut

Actif, ne recrute pas

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Estimé)

1955

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Royaume-Uni
    • West Yorkshire
      • Leeds, West Yorkshire, Royaume-Uni, LS2 9JT
        • University of Leeds

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

30 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
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
Délai: 6 months

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
Délai: 5 years

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
Délai: 10 years

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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Délai: 6 months

Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
6 months
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Délai: 5 years

Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
5 years
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Délai: 10 years

Number (%) of participants who receive an oral anticoagulant prescription after diagnoses of AF during ECG monitoring diagnosed
10 years

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
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
Délai: 6 months

Risk of recorded AF diagnosis in EHR between individuals identified at higher and lower risk at six months after enrolment
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
Délai: 6 months

Diagnostic yield, PPV, NPV, sensitivity and specificity amongst participants who receive ECG monitoring, to understand whether the numeric score at which a clinician implements ECG monitoring can be optimised
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:
Délai: 6 months

Diagnostic yield, C statistic/AUROC, PPV, NPV, sensitivity and specificity in patients who are : CHA2DS2VASC≥3 in men and CHA2DS2VASC≥4 in women, age ≥70 years and age 75 and 76 years
6 months
To determine if yield from ECG monitoring varies across age groups (≥75 years and ≤75 years) and sex (men and women)
Délai: 6 months

AF detection rates and risks comparing higher and lower risk participants stratified by subgroup
6 months
To determine recruitment rates, overall study.
Délai: Up to 24 months

Number (%) of people who consent to participate compared to number of people who are invited
Up to 24 months
To determine withdrawal rates
Délai: Up to 24 months

Number (%) of people who consent to participate but subsequently withdraw consent / decline ECG monitoring
Up to 24 months
To determine if there are differences between those who participate and those that do not participate
Délai: Up to 24 months

Characteristics of those who consent to participate and do not consent to participate
Up to 24 months
To determine if there are differences between those who participate and those that withdraw
Délai: Up to 24 months

Characteristics of those who participate and those that withdraw
Up to 24 months
To determine the adherence of ECG recordings amongst participants
Délai: Up to 24 months

Mean number of recordings compared to the maximum stipulated Number (%) of participants who record less than 50% of stipulated amount of ECG recordings
Up to 24 months
To determine the number of ECG recordings that need to be reviewed for possible AF detection
Délai: Up to 24 months

Number (%) of ECG recordings flagged as abnormal by the algorithm within ECG recorder software that require manual review to assess for potential AF diagnosis
Up to 24 months
To determine the burden of other arrhythmias that are diagnosed through ECG monitoring in participants identified as higher risk and lower risk
Délai: Up to 24 months

Number (%) of participants who are diagnosed with other arrhythmias ( (atrial tachycardia, supraventricular tachycardia, 2nd degree AV block, high grade AV block or 3rd degree heart block, pause/asystole, ventricular tachycardia, ventricular fibrillation) during ECG monitoring in participants
Up to 24 months
To determine the burden of non-diagnostic rhythm reports from ECG monitoring
Délai: Up to 24 months

Number (%) of participants who have an ECG monitoring period with consistent poor quality which precludes a diagnostic result
Up to 24 months
To determine recruitment rates - research clinic appointment
Délai: Up to 24 months

Number (%) of people who consent to attend a research clinic appointment compared to number of people who are invited
Up to 24 months
To determine what other conditions and cardiovascular risk factors are identified amongst participants classified as higher risk for AF at research clinic
Délai: End of recruitment

Descriptive statistics of demographics, morbidities, medications, and cardiac ultrasound findings
End of recruitment
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?
Délai: 5 years from completion of recruitment

Number (%) of participants who experience at 5 years:

  • AF
  • Ischaemic stroke
  • Haemorrhagic stroke
  • Systemic embolism
  • Gastrointestinal or intracranial bleeding
  • Death
  • Chronic obstructive pulmonary disease
  • Chronic kidney disease
  • Heart failure
  • Diabetes mellitus
  • Myocardial infarction
  • Peripheral vascular disease
  • Valvular heart disease
5 years from completion of recruitment
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?
Délai: 10 years from completion of recruitment

Number (%) of participants who experience at 10 years:

  • AF
  • Ischaemic stroke
  • Haemorrhagic stroke
  • Systemic embolism
  • Gastrointestinal or intracranial bleeding
  • Death
  • Chronic obstructive pulmonary disease
  • Chronic kidney disease
  • Heart failure
  • Diabetes mellitus
  • Myocardial infarction
  • Peripheral vascular disease
  • Valvular heart disease
10 years from completion of recruitment

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Leeds

Collaborateurs

The Leeds Teaching Hospitals NHS Trust
British Heart Foundation
Daiichi Sankyo

Les enquêteurs

  • Chercheur principal: Chris Gale, Yes, University of Leeds

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 octobre 2023

Achèvement primaire (Réel)

16 juin 2025

Achèvement de l'étude (Estimé)

28 février 2033

Dates d'inscription aux études

Première soumission

18 mai 2023

Première soumission répondant aux critères de contrôle qualité

31 mai 2023

Première publication (Réel)

12 juin 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

2 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 318197_V1.0_230509

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No individual participant data will be shared.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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