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Completed

NCT Number: NCT02262351

Program for the Identification of "Actionable" Atrial Fibrillation in the Family Practice Setting

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Family Medical Centre, Black Diamond, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

30 Second Pulse Check

Other

To detect atrial fibrillation

Watch BP Home A

Device

Blood pressure device that detects atrial fibrillation

HeartCheck Hand-held ECG device

Device

To detect atrial fibrillation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Acronym: PIAAF-FP

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2014
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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