- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02262351
Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting (PIAAF-FP)
October 4, 2018 updated by: Population Health Research Institute
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
2174
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Black Diamond, Alberta, Canada
- Foothills Family Medical Centre
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Calgary, Alberta, Canada
- Crowfoot Village Family Practice
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Camrose, Alberta, Canada
- Smith Clinic, Camrose PCN
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Edmonton, Alberta, Canada
- Abbottsfield Medical Centre
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Edmonton, Alberta, Canada
- Alta Clinical Research
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Edmonton, Alberta, Canada
- Edmonton Oliver PCN
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Olds, Alberta, Canada
- Peaks to Prairies PCN
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Ontario
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Hamilton, Ontario, Canada
- Hamilton Medical Clinic
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Kingston, Ontario, Canada
- Queen's Family Health Team
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Kirkfield, Ontario, Canada
- Kirkfield Medical Centre
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Markham, Ontario, Canada
- Ken Ng Family Practice / Total Health Management
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Newmarket, Ontario, Canada
- SKDS Research Inc
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Owen Sound, Ontario, Canada
- Dr. Mark Robertson Family Practice
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Thunder Bay, Ontario, Canada
- The Port Arthur Clinic Research Program
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Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
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Toronto, Ontario, Canada
- Women's College Hospital
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Toronto, Ontario, Canada
- Mount Dennis Weston Health Centre
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Toronto, Ontario, Canada
- Village Health Centre
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Waterloo, Ontario, Canada
- Sameh Fikry Medicine Professional Corporation
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥65 years.
- Attending their usual Primary Care Clinic.
- Provide written informed consent.
Exclusion Criteria:
Patients considered by the Investigator to be unsuitable for study follow-up because the patient:
- is unreliable concerning the follow-up schedule
- cannot be contacted by telephone
- has a life expectancy less than the anticipated study duration due to concomitant disease.
- Presence of an implanted pacemaker or defibrillator.
- Inability to have a BP cuff applied.
- Documented significant allergy to ECG electrode adhesive.
- Previously screened as part of this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Screening
Subjects will undergo three screening methods for atrial fibrillation: 30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device |
To detect atrial fibrillation
Blood pressure device that detects atrial fibrillation
To detect atrial fibrillation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance of screening tests
Time Frame: 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.
|
Baseline visit
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Cost of each method per case of actionable AF detected
Time Frame: 90 days
|
90 days
|
Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints
Time Frame: 90 days
|
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
|
90 days
|
Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.
Time Frame: 90 days
|
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
|
90 days
|
Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.
Time Frame: 90 days
|
90 days
|
Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.
Time Frame: 90 days
|
90 days
|
Time taken for each screening test
Time Frame: Baseline
|
Baseline
|
Death rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Stroke or transient ischemic attack rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Systemic embolism rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Myocardial infarction rate rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Significant bleeding rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Hospitalization due to heart failure rate for each case of actionable AFib identified
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: F. Russell Quinn, MRCP PhD, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Quinn FR, Gladstone DJ, Ivers NM, Sandhu RK, Dolovich L, Ling A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Diagnostic accuracy and yield of screening tests for atrial fibrillation in the family practice setting: a multicentre cohort study. CMAJ Open. 2018 Aug 2;6(3):E308-E315. doi: 10.9778/cmajo.20180001. Print 2018 Jul-Sep.
- Tarride JE, Quinn FR, Blackhouse G, Sandhu RK, Burke N, Gladstone DJ, Ivers NM, Dolovich L, Thornton A, Nakamya J, Ramasundarahettige C, Frydrych PA, Henein S, Ng K, Congdon V, Birtwhistle RV, Ward R, Healey JS. Is Screening for Atrial Fibrillation in Canadian Family Practices Cost-Effective in Patients 65 Years and Older? Can J Cardiol. 2018 Nov;34(11):1522-1525. doi: 10.1016/j.cjca.2018.05.016. Epub 2018 Jun 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2015
Primary Completion (Actual)
October 15, 2016
Study Completion (Actual)
December 2, 2016
Study Registration Dates
First Submitted
September 30, 2014
First Submitted That Met QC Criteria
October 7, 2014
First Posted (Estimate)
October 13, 2014
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 4, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PIAAF-FP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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