Atrial FibrillationPIAAF-FPNCT02262351
Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
A study testing 30 Second Pulse Check, Watch BP Home A and HeartCheck Hand-held ECG device in people with Atrial Fibrillation, run by Population Health Research Institute at 19 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- 30 Second Pulse Check, Watch BP Home A and HeartCheck Hand-held ECG device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,174 participants
- Where
- 19 sitesCanada
- Study dates
- Apr 2015to 2 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 years.
- Attending their usual Primary Care Clinic.
- Provide written informed consent.
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Canada19 sites
Foothills Family Medical Centre
Black Diamond, Alberta
Crowfoot Village Family Practice
Calgary, Alberta
Smith Clinic, Camrose PCN
Camrose, Alberta
Abbottsfield Medical Centre
Edmonton, Alberta
Alta Clinical Research
Edmonton, Alberta
Edmonton Oliver PCN
Edmonton, Alberta
Hamilton Medical Clinic
Hamilton, Ontario
Queen's Family Health Team
Kingston, Ontario
Kirkfield Medical Centre
Kirkfield, Ontario
Ken Ng Family Practice / Total Health Management
Markham, Ontario
SKDS Research Inc
Newmarket, Ontario
Peaks to Prairies PCN
Olds, Alberta
Dr. Mark Robertson Family Practice
Owen Sound, Ontario
The Port Arthur Clinic Research Program
Thunder Bay, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mount Dennis Weston Health Centre
Toronto, Ontario
Village Health Centre
Toronto, Ontario
Women's College Hospital
Toronto, Ontario
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario
About this study
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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- 30 Second Pulse Check, Watch BP Home A, HeartCheck Hand-held ECG device
- Keywords
- Atrial Fibrillation, Screening, Family Practice, Novel screening technologies
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30 Second Pulse CheckOther
To detect atrial fibrillation
Watch BP Home ADevice
Blood pressure device that detects atrial fibrillation
HeartCheck Hand-held ECG deviceDevice
To detect atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| Screening | Experimental | Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device Receives: Other: 30 Second Pulse Check; Device: Watch BP Home A; Device: HeartCheck Hand-held ECG device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline visit
Secondary outcomes (14)
Cost of each method per case of actionable AF detected
Measured: 90 days
Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints
Measured: 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
Measured: 90 days
Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.
Measured: 90 days
Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).
Measured: 90 days
Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.
Measured: 90 days
Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.
Measured: 90 days
Time taken for each screening test
Measured: Baseline
Death rate for each case of actionable AFib identified
Measured: 90 days
Stroke or transient ischemic attack rate for each case of actionable AFib identified
Measured: 90 days
Systemic embolism rate for each case of actionable AFib identified
Measured: 90 days
Myocardial infarction rate rate for each case of actionable AFib identified
Measured: 90 days
Significant bleeding rate for each case of actionable AFib identified
Measured: 90 days
Hospitalization due to heart failure rate for each case of actionable AFib identified
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startApr 2015
- Primary completion15 Oct 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- F. Russell Quinn, MRCP PhD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02262351
- Sponsor's protocol ID
- PIAAF-FP
- Acronym
- PIAAF-FP
- Status last verified
- Oct 2018
- First submitted
- 30 Sep 2014
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30072410Tarride 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.
PubMed 30144961
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
- ClinicalTrials.gov ID
- NCT02262351
- Acronym / sponsor ID
- PIAAF-FP / PIAAF-FP
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Screening, Family Practice, Novel screening technologies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,174 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2015 (actual)
- Primary completion
- 15 Oct 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 13 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening | Experimental | Other: 30 Second Pulse Check, Device: Watch BP Home A, Device: HeartCheck Hand-held ECG deviceSubjects will undergo three screening methods for atrial fibrillation: 30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥65 years.
- Attending their usual Primary Care Clinic.
- Provide written informed consent.
Key exclusion criteria (8 listed)
- Patients considered by the Investigator to be unsuitable for study follow-up because the patient:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30 Second Pulse CheckTo detect atrial fibrillation | Other | Screening |
| Watch BP Home ABlood pressure device that detects atrial fibrillation | Device | Screening |
| HeartCheck Hand-held ECG deviceTo detect atrial fibrillation | Device | Screening |
Primary outcome
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.
14 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Results publication: PubMed 30072410Quinn 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.
- Results publication: PubMed 30144961Tarride 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Russell Quinn, MRCP PhD principal investigator
University of Calgary
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30 Second Pulse Check, Watch BP Home A and HeartCheck Hand-held ECG device in people with Atrial Fibrillation, run by Population Health Research Institute at 19 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of screening tests (time frame: Baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02262351, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2018.