Clinical trial NCT02392754: Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older
Official title: Program for Identification of "Actionable" Atrial Fibrillation (PIAAF): Home-Based Screening for Early Detection of Atrial Fibrillation in Primary Care Patients Aged 75 Years and Older: the SCREEN-AF Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Hypertension
Keywords: Screening
Atrial Fibrillation
ECG
Primary care
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Stroke Prevention Intervention Network
name: Canadian Institutes of Health Research (CIHR)
name: Heart and Stroke Foundation of Canada
name: Canadian Stroke Network
name: iRhythm Technologies, Inc.
name: Microlife
name: University of Leipzig
name: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
First posted: 2015-03-19
Enrollment: 856
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Atrial fibrillation (AF) is a major treatable risk factor for stroke, but it may be hard to detect because it is frequently silent and intermittent. New ambulatory cardiac monitoring technologies have the potential to improve early detection of AF. This trial investigates AF screening in primary care patients using the ZIO XT Patch, a wearable adhesive patch monitor that provides continuous ECG recording for up to 14 days, in addition to the WatchBP home blood pressure monitor that has built-in AF screening capability.

Detailed description: SCREEN-AF is an investigator-initiated, multicenter, open-label, two-group randomized controlled trial investigating non-invasive, home-based AF screening. The trial targets patients aged 75 years or older with a history of hypertension and without known AF who would be potential anticoagulant candidates if AF were detected. Eligible participants will be recruited from primary care practices and randomly allocated (1:1) to one of two groups:

* The control group will receive standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months).
* The intervention group will undergo ambulatory screening for AF with a 2-week continuous ECG patch monitor worn at baseline and again at 3 months, in addition to standard care for 6 months (including a pulse check and heart auscultation by a physician at baseline and 6 months). The intervention group will also receive a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring blocks.

The hypothesis is that continuous ambulatory cardiac rhythm monitoring using an adhesive ECG patch monitor will be superior to standard care for AF detection. The overall aim of this research is to establish a practical and cost-effective screening strategy that could be applied in primary care for early detection of AF in patients who would benefit from anticoagulant therapy if AF were detected. The ultimate goal of this primary prevention initiative is to prevent more strokes, and stroke-related deaths, disability, dementia, hospitalizations and institutionalization, through the early detection and treatment of AF.

Eligibility criteria: Inclusion Criteria:

1. Age ≥75 years without known atrial fibrillation or atrial flutter.
2. The participant is clinically in sinus rhythm (both heart auscultation and 30- second pulse palpation have been performed by the enrolling physician and neither detects an irregular rhythm suggestive of atrial fibrillation).
3. History of hypertension requiring antihypertensive medication.
4. Written informed consent from the participant.

Exclusion Criteria:

1. Any previously documented atrial fibrillation or atrial flutter ≥30 seconds.
2. Implanted pacemaker, cardiac defibrillator, cardiac loop recorder, or deep brain stimulator.
3. Likely to be poorly compliant or unreliable using home screening devices or with study follow-up requirements because of cognitive or other issues, or life expectancy \<6 months due to concomitant disease.
4. Has a condition which in the opinion of the enrolling physician would not permit chronic treatment with oral anticoagulant therapy.
5. Patient already taking long-term oral anticoagulant therapy.
6. Known allergic reaction/intolerance to skin adhesives.

Primary outcomes:
measure: Detection of new atrial fibrillation or flutter
timeFrame: within 6 month from randomization
Secondary outcomes:
measure: Prescription of oral anticoagulation therapy
timeFrame: within 6 months from randomization
measure: Primary endpoint detected by ECG patch monitor
timeFrame: within 6 months from randomization
measure: Atrial fibrillation episodes of various durations (detection of any AF episode ≥30 seconds, ≥30 seconds to 5 minutes, >5 hours, and >24 hours (to facilitate comparison with other studies in the literature)
timeFrame: within 6 months from randomization
measure: Adherence, tolerability and patient satisfaction with screening devices
timeFrame: within 6 months of randomization
measure: Clinical outcome events
timeFrame: within 6 months from randomization
measure: Cost effectiveness of screening
timeFrame: within 6 months from randomization
measure: Detection of other (non-AF) clinically important arrhythmias
timeFrame: within 6 months from randomization
measure: Sensitivity and specificity of Watch BP Home-A monitor ( false positive rate of a home AF-BP monitor (with ECG patch monitor as the gold standard).
timeFrame: within 6 months from randomization
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Crowfoot Village Family Practice
state: Alberta
city: Camrose
country: Canada
facility: Smith Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton Oliver PCN
state: Alberta
city: Olds
country: Canada
facility: Peaks to Praries PCN
state: Alberta
city: Ayr
country: Canada
facility: Henry Vlaar FP
state: Ontario
city: Burlington
country: Canada
facility: LMC / Manna Research
state: Ontario
city: Etobicoke
country: Canada
facility: Humber River FHT - Dixon Site
state: Ontario
city: Georgetown
country: Canada
facility: Halton Hills FHT
state: Ontario
city: Haileybury
country: Canada
facility: Haileybury FHT
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton Medical Clinic
state: Ontario
city: Kingston
country: Canada
facility: Queen's Family Health Team
state: Ontario
city: Markham
country: Canada
facility: Ken Ng FP / Total Health Management
state: Ontario
city: Morrisburg
country: Canada
facility: St. Lawrence Medical Clinic
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research Inc.
state: Ontario
city: Oakville
country: Canada
facility: OakMed FHT
state: Ontario
city: Owen Sound
country: Canada
facility: Mark Robertson Family Practice
state: Ontario
city: St. Catharines
country: Canada
facility: Michael Kopp Family Practice / N Fung & M Kopp Medicine Professional Corporation
state: Ontario
city: St. Catherines
country: Canada
facility: Garden City FHT
state: Ontario
city: Stouffville
country: Canada
facility: Health for All FHT
state: Ontario
city: Thunder Bay
country: Canada
facility: Port Arthur Health Centre
state: Ontario
city: Toronto
country: Canada
facility: Keele Medical Place
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Toronto
country: Canada
facility: Mount Dennis Weston Health Centre
state: Ontario
city: Waterloo
country: Canada
facility: Sameh Fikry Medicine Professional Corporation
state: Ontario
city: Frankfurt am Main
country: Germany
facility: Goethe University Frankfurt am Main
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Hamburg University Medical School
Study officials:
affiliation: Sunnybrook Research Institute, University of Toronto
name: David J. Gladstone, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gladstone DJ, Wachter R, Schmalstieg-Bahr K, Quinn FR, Hummers E, Ivers N, Marsden T, Thornton A, Djuric A, Suerbaum J, von Grunhagen D, McIntyre WF, Benz AP, Wong JA, Merali F, Henein S, Nichol C, Connolly SJ, Healey JS; SCREEN-AF Investigators and Coordinators. Screening for Atrial Fibrillation in the Older Population: A Randomized Clinical Trial. JAMA Cardiol. 2021 May 1;6(5):558-567. doi: 10.1001/jamacardio.2021.0038.