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Przyszłe innowacje w nowatorskim wykrywaniu migotania przedsionków (FIND-AF): badanie pilotażowe (FIND-AF)

30 września 2026 zaktualizowane przez: Prof Christopher Gale, University of Leeds

Przyszłe innowacje w nowatorskim wykrywaniu migotania przedsionków (FIND-AF): badanie pilotażowe oceny ryzyka we wczesnym wykrywaniu migotania przedsionków

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.

Przegląd badań

Status

Aktywny, nie rekrutujący

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1955

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Zjednoczone Królestwo
    • West Yorkshire
      • Leeds, West Yorkshire, Zjednoczone Królestwo, LS2 9JT
        • University of Leeds

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

30 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: COHORT
  • Perspektywy czasowe: PROSPECTIVE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
To determine, of participants who are detected as having AF during ECG monitoring, the proportion who subsequently receive oral anticoagulation prescription
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 10 years

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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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:
Ramy czasowe: 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)
Ramy czasowe: 6 months

AF detection rates and risks comparing higher and lower risk participants stratified by subgroup
6 months
To determine recruitment rates, overall study.
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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?
Ramy czasowe: 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?
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

University of Leeds

Współpracownicy

The Leeds Teaching Hospitals NHS Trust
British Heart Foundation
Daiichi Sankyo

Śledczy

  • Główny śledczy: Chris Gale, Yes, University of Leeds

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 października 2023

Zakończenie podstawowe (Rzeczywisty)

16 czerwca 2025

Ukończenie studiów (Szacowany)

28 lutego 2033

Daty rejestracji na studia

Pierwszy przesłany

18 maja 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

31 maja 2023

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

2 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

30 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 318197_V1.0_230509

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

No individual participant data will be shared.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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