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Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting (PIAAF-FP)

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ClinicalTrials.gov Identifier: NCT02262351
Recruitment Status : Completed
First Posted : October 13, 2014
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Population Health Research Institute

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: 30 Second Pulse Check Device: Watch BP Home A Device: HeartCheck Hand-held ECG device Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2174 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting
Actual Study Start Date : April 2015
Actual Primary Completion Date : October 15, 2016
Actual Study Completion Date : December 2, 2016

Resource links provided by the National Library of Medicine


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

Other: 30 Second Pulse Check
To detect atrial fibrillation

Device: Watch BP Home A
Blood pressure device that detects atrial fibrillation

Device: HeartCheck Hand-held ECG device
To detect atrial fibrillation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Cost of each method per case of actionable AF detected [ Time Frame: 90 days ]
  2. Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints [ Time Frame: 90 days ]
  3. 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 ]
  4. Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days. [ Time Frame: 90 days ]
  5. Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities). [ Time Frame: 90 days ]
  6. Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire. [ Time Frame: 90 days ]
  7. Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF. [ Time Frame: 90 days ]
  8. Time taken for each screening test [ Time Frame: Baseline ]
  9. Death rate for each case of actionable AFib identified [ Time Frame: 90 days ]
  10. Stroke or transient ischemic attack rate for each case of actionable AFib identified [ Time Frame: 90 days ]
  11. Systemic embolism rate for each case of actionable AFib identified [ Time Frame: 90 days ]
  12. Myocardial infarction rate rate for each case of actionable AFib identified [ Time Frame: 90 days ]
  13. Significant bleeding rate for each case of actionable AFib identified [ Time Frame: 90 days ]
  14. Hospitalization due to heart failure rate for each case of actionable AFib identified [ Time Frame: 90 days ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02262351


Locations
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Canada, Alberta
Foothills Family Medical Centre
Black Diamond, Alberta, Canada
Crowfoot Village Family Practice
Calgary, Alberta, Canada
Smith Clinic, Camrose PCN
Camrose, Alberta, Canada
Abbottsfield Medical Centre
Edmonton, Alberta, Canada
Alta Clinical Research
Edmonton, Alberta, Canada
Edmonton Oliver PCN
Edmonton, Alberta, Canada
Peaks to Prairies PCN
Olds, Alberta, Canada
Canada, Ontario
Hamilton Medical Clinic
Hamilton, Ontario, Canada
Queen's Family Health Team
Kingston, Ontario, Canada
Kirkfield Medical Centre
Kirkfield, Ontario, Canada
Ken Ng Family Practice / Total Health Management
Markham, Ontario, Canada
SKDS Research Inc
Newmarket, Ontario, Canada
Dr. Mark Robertson Family Practice
Owen Sound, Ontario, Canada
The Port Arthur Clinic Research Program
Thunder Bay, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Dennis Weston Health Centre
Toronto, Ontario, Canada
Village Health Centre
Toronto, Ontario, Canada
Women's College Hospital
Toronto, Ontario, Canada
Sameh Fikry Medicine Professional Corporation
Waterloo, Ontario, Canada
Sponsors and Collaborators
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: F. Russell Quinn, MRCP PhD University of Calgary

Publications of Results:
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Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02262351     History of Changes
Other Study ID Numbers: PIAAF-FP
First Posted: October 13, 2014    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Keywords provided by Population Health Research Institute:
Atrial Fibrillation
Screening
Family Practice
Novel screening technologies
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes