This trial is active, not recruiting.

Condition atrial fibrillation
Treatments 30 second pulse check, watch bp home a, heartcheck hand-held ecg device
Sponsor Population Health Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date April 2015
End date October 2016
Trial size 2174 participants
Trial identifier NCT02262351, PIAAF-FP


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose screening
Subjects will undergo three screening methods for atrial fibrillation: 30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
30 second pulse check
To detect atrial fibrillation
watch bp home a
Blood pressure device that detects atrial fibrillation
heartcheck hand-held ecg device
To detect atrial fibrillation

Primary Outcomes

Performance of screening tests
time frame: Baseline visit

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 65 years old.

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.

Additional Information

Official title Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
Principal investigator F. Russell Quinn, MRCP PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Population Health Research Institute.