Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Screening, Family Practice, Novel screening technologies
Brief summary
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.
Detailed description
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.
Interventions
OTHER30 Second Pulse Check
To detect atrial fibrillation
DEVICEWatch BP Home A
Blood pressure device that detects atrial fibrillation
DEVICEHeartCheck Hand-held ECG device
To detect atrial fibrillation
Sponsors
Canadian Institutes of Health Research (CIHR)
Population Health Research Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age ≥65 years. 2. Attending their usual Primary Care Clinic. 3. Provide written informed consent.
Exclusion criteria
1. Patients considered by the Investigator to be unsuitable for study follow-up because the patient: 1. is unreliable concerning the follow-up schedule 2. cannot be contacted by telephone 3. has a life expectancy less than the anticipated study duration due to concomitant disease. 2. Presence of an implanted pacemaker or defibrillator. 3. Inability to have a BP cuff applied. 4. Documented significant allergy to ECG electrode adhesive. 5. Previously screened as part of this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance of screening tests | Baseline visit | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints | 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 | 90 days |
| Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days. | 90 days |
| Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities). | 90 days |
| Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire. | 90 days |
| Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF. | 90 days |
| Cost of each method per case of actionable AF detected | 90 days |
| Death rate for each case of actionable AFib identified | 90 days |
| Stroke or transient ischemic attack rate for each case of actionable AFib identified | 90 days |
| Systemic embolism rate for each case of actionable AFib identified | 90 days |
| Myocardial infarction rate rate for each case of actionable AFib identified | 90 days |
| Significant bleeding rate for each case of actionable AFib identified | 90 days |
| Hospitalization due to heart failure rate for each case of actionable AFib identified | 90 days |
| Time taken for each screening test | Baseline |
Countries
Canada
Outcome results
None listed