Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment of AF is one of the best way to prevent stroke. The problem is that because AF may cause minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is known that as many as half of all patients with known AF may not be receiving appropriate anticoagulation for their condition. New technologies are making it possible to improve AF detection. Subjects in this study will be screened for AF using three simple methods: a 30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood pressure monitor with built-in AF screening capabilities. If more patients with AF can be detected, more patients will be able to receive guideline-recommended anticoagulant therapy, and more strokes, deaths, disability, and dementia will be prevented.
Participants will be screened for AF using three simple methods (pulse check, single-lead ECG, blood pressure machine with automated AF detection algorithms). Subjects screening positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF detected, clinical characteristics and medications will be compared at baseline and 90±14 days later.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
2,174
To detect atrial fibrillation
Blood pressure device that detects atrial fibrillation
To detect atrial fibrillation
Foothills Family Medical Centre
Black Diamond, Alberta, Canada
Crowfoot Village Family Practice
Calgary, Alberta, Canada
Smith Clinic, Camrose PCN
Camrose, Alberta, Canada
Abbottsfield Medical Centre
Edmonton, Alberta, Canada
Alta Clinical Research
Edmonton, Alberta, Canada
Edmonton Oliver PCN
Edmonton, Alberta, Canada
Peaks to Prairies PCN
Olds, Alberta, Canada
Hamilton Medical Clinic
Hamilton, Ontario, Canada
Queen's Family Health Team
Kingston, Ontario, Canada
Kirkfield Medical Centre
Kirkfield, Ontario, Canada
...and 9 more locations
Performance of screening tests
The sensitivity and specificity of SL-ECG and BP-AF will be separately compared with that of pulse palpation alone using McNemar's method. This method can be used when only those subjects screening positive attend for confirmatory testing (12-lead ECG ± Holter monitor). A 2-sided alpha of 0.025 will be used to allow for multiple comparisons. A further analysis will be performed using the SL-ECG data as the gold standard. To ensure adequate diagnostic quality, this analysis will only be performed if 5% or less of the overall SL-ECG tracings are deemed "uninterpretable". A bipolar ECG interpreted by a cardiologist has a reported 99% sensitivity and 96% specificity for the diagnosis of AF. If this exploratory analysis is performed it will enable estimation of the sensitivity and specificity of the pulse-check and BP-AF device.
Time frame: Baseline visit
Cost of each method per case of actionable AF detected
Time frame: 90 days
Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints
Time frame: 90 days
Prescription rates at 90±14 days for oral anticoagulant agents (OACs) and drugs for control of heart rate and/or rhythm for patients with actionable AF
Time frame: 90 days
Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.
Time frame: 90 days
Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).
Time frame: 90 days
Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.
Time frame: 90 days
Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.
Time frame: 90 days
Time taken for each screening test
Time frame: Baseline
Death rate for each case of actionable AFib identified
Time frame: 90 days
Stroke or transient ischemic attack rate for each case of actionable AFib identified
Time frame: 90 days
Systemic embolism rate for each case of actionable AFib identified
Time frame: 90 days
Myocardial infarction rate rate for each case of actionable AFib identified
Time frame: 90 days
Significant bleeding rate for each case of actionable AFib identified
Time frame: 90 days
Hospitalization due to heart failure rate for each case of actionable AFib identified
Time frame: 90 days
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