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

NCT02262351 | Completed

• 1 other identifier: PIAAF-FP
• Study Type: interventional
• Target: 2,174
• Locations: 1 country
• Sites: 19

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Screening; Family Practice; Novel screening technologies

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline visit

Secondary Outcomes (14)

• Cost of each method per case of actionable AF detected

  90 days

• Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints

  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

  90 days

• Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.

  90 days

• Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).

  90 days

Study Arms (1)

Screening

EXPERIMENTAL

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; Device: Watch BP Home A; Device: HeartCheck Hand-held ECG device

Interventions

30 Second Pulse Check OTHER

To detect atrial fibrillation

Screening

Watch BP Home A DEVICE

Blood pressure device that detects atrial fibrillation

Screening

HeartCheck Hand-held ECG device DEVICE

To detect atrial fibrillation

Screening

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Age ≥65 years.
• Attending their usual Primary Care Clinic.
• Provide written informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Population Health Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (19)

Foothills Family Medical Centre

Black Diamond, Alberta, Canada

Location

Crowfoot Village Family Practice

Calgary, Alberta, Canada

Location

Smith Clinic, Camrose PCN

Camrose, Alberta, Canada

Location

Abbottsfield Medical Centre

Edmonton, Alberta, Canada

Location

Alta Clinical Research

Edmonton, Alberta, Canada

Location

Edmonton Oliver PCN

Edmonton, Alberta, Canada

Location

Peaks to Prairies PCN

Olds, Alberta, Canada

Location

Hamilton Medical Clinic

Hamilton, Ontario, Canada

Location

Queen's Family Health Team

Kingston, Ontario, Canada

Location

Kirkfield Medical Centre

Kirkfield, Ontario, Canada

Location

Ken Ng Family Practice / Total Health Management

Markham, Ontario, Canada

Location

SKDS Research Inc

Newmarket, Ontario, Canada

Location

Dr. Mark Robertson Family Practice

Owen Sound, Ontario, Canada

Location

The Port Arthur Clinic Research Program

Thunder Bay, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Dennis Weston Health Centre

Toronto, Ontario, Canada

Location

Village Health Centre

Toronto, Ontario, Canada

Location

Women's College Hospital

Toronto, Ontario, Canada

Location

Sameh Fikry Medicine Professional Corporation

Waterloo, Ontario, Canada

Location

Related Publications (2)

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• F. Russell Quinn, MRCP PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2014
• First Posted: October 13, 2014
• Study Start: April 1, 2015
• Primary Completion: October 15, 2016
• Study Completion: December 2, 2016
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CA (19)