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

Atrial Fibrillation Clinical Trial

— PIAAF-FP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02262351
• Other study ID #: PIAAF-FP
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: December 2, 2016

Study information

• Verified date: October 2018
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2174
• Est. completion date: December 2, 2016
• Est. primary completion date: October 15, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• 30 Second Pulse Check
To detect atrial fibrillation

Device:
• Watch BP Home A
Blood pressure device that detects atrial fibrillation
• HeartCheck Hand-held ECG device
To detect atrial fibrillation

Locations

Country	Name	City	State
Canada	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	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	Peaks to Prairies PCN	Olds	Alberta
Canada	Dr. Mark Robertson Family Practice	Owen Sound	Ontario
Canada	The Port Arthur Clinic Research Program	Thunder Bay	Ontario
Canada	Mount Dennis Weston Health Centre	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario
Canada	Village Health Centre	Toronto	Ontario
Canada	Women's College Hospital	Toronto	Ontario
Canada	Sameh Fikry Medicine Professional Corporation	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

References & 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 fa — View 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 Can — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost of each method per case of actionable AF detected		90 days
Secondary	Cost-effectiveness measures based on each screening test and their potential impact on stroke and other clinical endpoints		90 days
Secondary	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
Secondary	Relationship between CHADS2 and CHA2DS2-VASc scores and prescription rates for OACs at 90±14 days.		90 days
Secondary	Number needed to screen to detect one case of AF, in relation to demographic and clinical characteristics (gender, age, comorbidities).		90 days
Secondary	Screener and patient experiences with the different screening methods, assessed by satisfaction questionnaire.		90 days
Secondary	Resting heart rate & BP at baseline and 90±14 days for patients with newly diagnosed AF.		90 days
Secondary	Time taken for each screening test		Baseline
Secondary	Death rate for each case of actionable AFib identified		90 days
Secondary	Stroke or transient ischemic attack rate for each case of actionable AFib identified		90 days
Secondary	Systemic embolism rate for each case of actionable AFib identified		90 days
Secondary	Myocardial infarction rate rate for each case of actionable AFib identified		90 days
Secondary	Significant bleeding rate for each case of actionable AFib identified		90 days
Secondary	Hospitalization due to heart failure rate for each case of actionable AFib identified		90 days