<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02262351</url>
  </required_header>
  <id_info>
    <org_study_id>PIAAF-FP</org_study_id>
    <nct_id>NCT02262351</nct_id>
  </id_info>
  <brief_title>Program for the Identification of &quot;Actionable&quot; Atrial Fibrillation in the Family Practice Setting</brief_title>
  <acronym>PIAAF-FP</acronym>
  <official_title>Program for the Identification of &quot;Actionable&quot; Atrial Fibrillation in the Family Practice Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Canadian Institutes of Health Research (CIHR)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Population Health Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Atrial fibrillation (AF) is a major risk factor for stroke. The identification and treatment&#xD;
      of AF is one of the best way to prevent stroke. The problem is that because AF may cause&#xD;
      minimal symptoms, it often goes undetected before a patient suffers a stroke. Also, it is&#xD;
      known that as many as half of all patients with known AF may not be receiving appropriate&#xD;
      anticoagulation for their condition. New technologies are making it possible to improve AF&#xD;
      detection. Subjects in this study will be screened for AF using three simple methods: a&#xD;
      30-second pulse check, a hand-held single-lead electrocardiogram (ECG) device and a blood&#xD;
      pressure monitor with built-in AF screening capabilities. If more patients with AF can be&#xD;
      detected, more patients will be able to receive guideline-recommended anticoagulant therapy,&#xD;
      and more strokes, deaths, disability, and dementia will be prevented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be screened for AF using three simple methods (pulse check, single-lead&#xD;
      ECG, blood pressure machine with automated AF detection algorithms). Subjects screening&#xD;
      positive on any test will attend for a 12-lead ECG within 24 h. For all patients with AF&#xD;
      detected, clinical characteristics and medications will be compared at baseline and 90±14&#xD;
      days later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Actual">December 2, 2016</completion_date>
  <primary_completion_date type="Actual">October 15, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of screening tests</measure>
    <time_frame>Baseline visit</time_frame>
    <description>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 &quot;uninterpretable&quot;. 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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost of each method per case of actionable AF detected</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Resting heart rate &amp; BP at baseline and 90±14 days for patients with newly diagnosed AF.</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time taken for each screening test</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke or transient ischemic attack rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Systemic embolism rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction rate rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Significant bleeding rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization due to heart failure rate for each case of actionable AFib identified</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2174</enrollment>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Screening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will undergo three screening methods for atrial fibrillation:&#xD;
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>30 Second Pulse Check</intervention_name>
    <description>To detect atrial fibrillation</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Watch BP Home A</intervention_name>
    <description>Blood pressure device that detects atrial fibrillation</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HeartCheck Hand-held ECG device</intervention_name>
    <description>To detect atrial fibrillation</description>
    <arm_group_label>Screening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥65 years.&#xD;
&#xD;
          2. Attending their usual Primary Care Clinic.&#xD;
&#xD;
          3. Provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients considered by the Investigator to be unsuitable for study follow-up because&#xD;
             the patient:&#xD;
&#xD;
               1. is unreliable concerning the follow-up schedule&#xD;
&#xD;
               2. cannot be contacted by telephone&#xD;
&#xD;
               3. has a life expectancy less than the anticipated study duration due to concomitant&#xD;
                  disease.&#xD;
&#xD;
          2. Presence of an implanted pacemaker or defibrillator.&#xD;
&#xD;
          3. Inability to have a BP cuff applied.&#xD;
&#xD;
          4. Documented significant allergy to ECG electrode adhesive.&#xD;
&#xD;
          5. Previously screened as part of this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>F. Russell Quinn, MRCP PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Calgary</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Family Medical Centre</name>
      <address>
        <city>Black Diamond</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crowfoot Village Family Practice</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Smith Clinic, Camrose PCN</name>
      <address>
        <city>Camrose</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbottsfield Medical Centre</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alta Clinical Research</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edmonton Oliver PCN</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peaks to Prairies PCN</name>
      <address>
        <city>Olds</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Medical Clinic</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's Family Health Team</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kirkfield Medical Centre</name>
      <address>
        <city>Kirkfield</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ken Ng Family Practice / Total Health Management</name>
      <address>
        <city>Markham</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SKDS Research Inc</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Mark Robertson Family Practice</name>
      <address>
        <city>Owen Sound</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Port Arthur Clinic Research Program</name>
      <address>
        <city>Thunder Bay</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Dennis Weston Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Village Health Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Women's College Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sameh Fikry Medicine Professional Corporation</name>
      <address>
        <city>Waterloo</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <results_reference>
    <citation>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.</citation>
    <PMID>30072410</PMID>
  </results_reference>
  <results_reference>
    <citation>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.</citation>
    <PMID>30144961</PMID>
  </results_reference>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 4, 2018</last_update_submitted>
  <last_update_submitted_qc>October 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Atrial Fibrillation</keyword>
  <keyword>Screening</keyword>
  <keyword>Family Practice</keyword>
  <keyword>Novel screening technologies</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atrial Fibrillation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02262351
org study id: PIAAF-FP
nct id: NCT02262351
lead sponsor: 
collaborator: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Performance of screening tests
time frame: Baseline visit
description: 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.
measure: Cost of each method per case of actionable AF detected
time frame: 90 days
measure: Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints
time frame: 90 days
measure: 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
measure: Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.
time frame: 90 days
measure: Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).
time frame: 90 days
measure: Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.
time frame: 90 days
measure: Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.
time frame: 90 days
measure: Time taken for each screening test
time frame: Baseline
measure: Death rate for each case of actionable AFib identified
time frame: 90 days
measure: Stroke or transient ischemic attack rate for each case of actionable AFib identified
time frame: 90 days
measure: Systemic embolism rate for each case of actionable AFib identified
time frame: 90 days
measure: Myocardial infarction rate rate for each case of actionable AFib identified
time frame: 90 days
measure: Significant bleeding rate for each case of actionable AFib identified
time frame: 90 days
measure: Hospitalization due to heart failure rate for each case of actionable AFib identified
time frame: 90 days
arm group label: Screening
arm group type: Experimental
description: Subjects will undergo three screening methods for atrial fibrillation:
30 Second Pulse Check Watch BP Home A HeartCheck Hand-held ECG device
intervention type: Other
intervention name: 30 Second Pulse Check
description: To detect atrial fibrillation
arm group label: Screening
intervention type: Device
intervention name: Watch BP Home A
description: Blood pressure device that detects atrial fibrillation
arm group label: Screening
intervention type: Device
intervention name: HeartCheck Hand-held ECG device
description: To detect atrial fibrillation
arm group label: Screening
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: F. Russell Quinn, MRCP PhD
role: Principal Investigator
affiliation: University of Calgary
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
citation: 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.
PMID: 30072410
citation: 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.
PMID: 30144961
responsible party type: Sponsor
mesh term: Atrial Fibrillation