Personalized approach using wearable technology for early detection of Atrial Fibrillation (PATCH-AF)
Description: Vraagstuk: Ouderen met de hartritmestoornis atriumfibrilleren (AF) hebben een verhoogd risico op een beroerte. Tijdige opsporing van AF leidt tot minder beroertes. Wij onderzoeken of het gebruik van een ECG-pleister onder ouderen kan bijdragen aan eerdere opsporing van AF. Onderzoek: In 20 huisartspraktijken selecteren wij mensen van 65 jaar of ouder zonder AF. In 10 praktijken bieden wij 65-plussers met het hoogste risico op AF jaarlijks een 7-daagse hartritmemeting middels ECG-pleister aan. Voor selectie gebruiken wij een risicomodel dat het risico op AF goed kan inschatten. In de overige 10 huisartspraktijken krijgen álle 65-plussers de gebruikelijke zorg zonder ECG-pleister. Verwachte uitkomsten: Wij verwachten dat het jaarlijks meten van het hartritme in de hoog-risicogroep leidt tot een hoger percentage gevonden AF. Als dit inderdaad het geval is, dan zou deze risico-geleide opsporing kunnen worden ingezet in alle huisartspraktijken om hiermee beroertes te kunnen voorkomen.\n\nApplication summary: BACKGROUND/AIM Atrial fibrillation (AF) is a cardiac arrhythmia with a lifetime risk of approximately one in four. The presence of AF strongly increases a person’s risk of stroke, dementia, as well as heart failure. Currently, one in five strokes is related to undetected AF. Approximately 70% of these strokes could have been prevented if AF would have been detected earlier and prophylactic anticoagulant therapy would have been started. However, in daily practice detecting AF can be quite challenging, as it often occurs in a paroxysmal form, meaning that many cases are left undiagnosed and thereby exposed to stroke when only using a single time-point assessment. Fortunately, due to advances in technology, we are now able to increase the chance of detecting paroxysmal AF with patient-friendly, non-obtrusive cardiac monitoring devices that allow for continuous arrhythmia detection for up to 7 days. This sets the stage for a program that targets individuals at high risk for AF for selective screening with this new technology. So who should be considered as high-risk individuals? Epidemiological studies show that AF occurs mostly in patients aged 65 and older. Moreover clinical risk scores have been developed that can further risk-stratify individuals. The CHA2DS2-VASc score, developed to determine initiation of anticoagulant therapy in patients with AF, also has the ability to predict the risk of AF and appears most favorable due to its ease-of-use and compatibility with electronic health records. We therefore aim to evaluate the diagnostic yield for AF when using continuous cardiac monitoring in older patients deemed at high risk (based on CHA2DS2-VASc) compared with routine practice. STUDY DESIGN We propose to conduct a general practice based, network-run, multi-center, cluster-randomized controlled trial comparing a targeted AF case-finding strategy with standard care. The network concerns the “Academisch Huisartsennetwerk AMC”, which includes data from almost a half million patients in the Amsterdam region. The network database is fed with information that is received quarterly via automated data extractions from the affiliated general practices. STUDY POPULATION The study aims to randomize 10 intervention and 10 control general practices from the network. In total we aim to enroll 1,900 patients of at least 65 years of age without known AF at baseline. In the intervention arm (n=950) all men with a CHA2DS2-VASc >=3 and all women with a CHA2DS2-VASc >=4 will be contacted for cardiac monitoring. This will be approximately 35% (n=333) of patients in the intervention group. INTERVENTION The intervention consists of performing a single-lead ECG followed by 7-day ECG-patch monitoring which will be performed at baseline, after one and two years, and will be performed by investigators who visit participants at home or at the practice. The ECG monitoring episodes will be assessed by cardiologists, and patients’ general practitioners will be informed of any relevant findings. OUTCOMES OF INTEREST The primary outcome measure will be the difference in detection of new AF between the intervention and control practices over three years of follow-up. We define AF as any arrhythmia that has the characteristics of AF and lasts at least 30 seconds. Secondary outcome measures are the time to diagnosis of AF, and other relevant cardiovascular outcomes, such as ischemic stroke, TIA, dementia, mild cognitive impairment, heart failure, systemic embolism, myocardial infarction or unstable angina, and death from any cause. SAMPLE SIZE / DATA ANALYSIS We aim to randomize 20 practices with each 95 patients (n=1,900) to obtain sufficient power (80%) to detect a three-year AF rate difference of 2.2% (6.63 vs 4.43%), allowing for 10% lost to follow-up. PROPOSED SECONDARY ANALYSES Given that this research proposal forms the basis of a PhD thesis we a priori propose a number of additional analyses. First, we propose to study the difference in detection of new AF in control practices participating in the trial versus detection of AF in non-participating general practices in the network. In this way we can learn whether participating in a trial on AF case finding as a control practice may lead to increased awareness of detecting AF, and thereby increase efforts to detect AF in the control group (i.e. the Hawthorne effect). Second, we will evaluate patient experience in the intervention group. Third, we would like to perform a descriptive study on work-up and treatment patterns among primary care physicians once they are informed that one of their patients has a new diagnosis of AF.\n\nKeywords: [{"boost": 1, "value": "hartritmestoornis"}, {"boost": 1, "value": "atriumfibrilleren"}]
Funder: ZonMw
Funding type: research
Funder scheme: ["Vroege opsporing"]
Start date: 2021-01-01
End date: 2025-07-31
Investigator: dr. R.E. Harskamp
Institution: Amsterdam UMC Locatie AMC
Funded outputs count: 0
Funder award ID: zonmw-555004203-26499
OpenAlex ID: G572080822